Atlas FDA

FRG

323 FDA 510(k) clearances · Product code

90 daysmedian time to decision
278 days90th percentile
323clearances measured

FDA profile

Official device name
Wrap, Sterilization
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6850
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 20 · 2018: 22 · 2020: 21 · 2024: 21 · 2025: 19 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology (K261897)O&M Halyard, Inc.2026-07-02
Dukal Crepe Paper Sterilization Wrap (K252823)Dukal, LLC2026-05-28
HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap (K253454)O&M Halyard, Inc.2026-05-18
Sterilization Pouch/Roll (K251347)Sterivic Medical Co., Ltd.2026-01-28
Self-Seal Sterilization Pouch and Roll (K251177)Guangdong Maidi Medical Co., Ltd.2025-12-12
Chex-All Sterilization Pouches and Tubes (K250306)Propper Manufacturing Co., Inc.2025-10-31
Sterilization Pouch and Roll (K243179)Yichang Xinxin Paper Products Co., Ltd.2025-06-26
GCI Sterilization Wrappers (K250321)George Courey, Inc.2025-06-06
Self Sealing Sterilization Pouches (K243721)Wellmed Dental Medical Supply Co., Ltd.2025-04-25
Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (K250011)Turbett Surgical2025-04-04
Sterilization Package/Reel (K241565)Anqing Clean Dental Instrument Technology Co., Ltd.2025-02-24
Medicom Sterilization Pouch and Reel (K243431)Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.2025-02-21
Sterilization Pouches and Reels (K242898)Shanghai Jianzhong Medical Packaging Co., Ltd.2025-02-21
CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) (K240438)Comercializadora Brever2024-11-04
Safe Secure Sterilization Pouches and Rolls (K242839)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.2024-10-16
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K242208)Primed Medical Products, Inc.2024-10-07
Perpak™ Sterilization Tyvek Pouch (K241123)Km Corp.2024-09-18
Medline Reusable Sterilization Wrappers (K234132)Medline Industries, LP2024-09-17
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050)O&M Halyard, Inc.2024-09-16
HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) (K240330)O&M Halyard, Inc.2024-08-07
Medicom Sterilization Wrap (K240862)Medicom Group, Inc.2024-06-21
Steriking® Pouch for Robotic Instruments (K232625)Wipak OY2024-06-07
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (K233777)Primed Medical Products, Inc.2024-05-24
Dukal SMS Sterilization Wrap (K233262)Dukal, LLC2024-03-22
Reliance® Fusion Sterilization Wraps (K230137)Ahlstrom-Munksjo Nonwovens, LLC2023-12-07
Steriking® LT-Blueline Pouches with Tyvek® (K231999)Wipak OY2023-09-07
Steriking® LT-Blueline Pouches with Tyvek® (K231996)Wipak OY2023-09-07
Sterilization Wrap (K223600)Wuhan Zonsen Medical Products Co., Ltd.2023-08-25
Vis-U-All Low Temperature Sterilization Pouches (K231500)STERIS Corporation2023-08-07
Tyvek Roll with CI for STERLINK Sterilizer (K223025)Plasmapp Co,., Ltd.2023-05-09
Sterilization Wrap (K222151)Kenpax International Limited2023-03-23
Sterilization Pouch and Roll (K221875)Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.2023-02-13
Steriking LT-Blueline Pouches with Tyvek (K221379)Wipak OY2023-01-04
SteriKing LT-Blueline Pouches with Tyvek (K221377)Wipak OY2022-12-22
Gemini Sterilization Wrap (K220365)Medline Industries, LP2022-10-06
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (K222440)Steris2022-09-09
Solidence Multipockets (K191131)Solidence Surgical Corporation2022-08-03
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (K214007)Owens & Minor (O&M) Halyard, Inc.2022-07-27
Steriking Packaging for Medical Devices (K221016)Wipak OY2022-05-05
CareGUARD Sterilization Wrap (K213907)Care Essentials Pty, Ltd.2022-03-14
Sterilization Wraps (K220133)Weihai Hongyu Nonwoven Fabric Products Co., Ltd.2022-03-10
Steiking Packaging for Medical Devices (K210810)Wipak OY2022-01-23
SterileRight sterilization pouch and roll (K212338)Sterileright Packaging Mfg., Inc.2021-11-01
Tyvek(R) Roll with CI for STERLINKTM Sterilizer (K212198)Plasmapp Co,., Ltd.2021-10-22
Turbett Instrument Pod (K202593)Turbett Surgical, Inc.2021-05-19
SIGMA Sterilization Pouch and Roll (K202462)Sigma Medical Supplies Corporation2021-04-23
Tyvek Sterilization Pouches with Chevron Seal (K200336)Andersen Sterilizers, Inc.2020-11-12
Sterisheet Sterilization Wrap (K200335)Andersen Sterilizers, Inc.2020-11-12
Turbett Instrument Pod (K200240)Turbett Surgical, Inc.2020-04-30
Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K193561)Weihai Xingtai Packaging Products Co., Ltd.2020-04-15
Gemini Titan Sterilization Wrap (K192641)Medline Industries, Inc.2020-01-24
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) (K182184)Mdk (Shanghai) Medical Packing Co., Ltd.2019-10-10
Halyard ONE-STEP* Sterilization Wrap (K192147)Owens & Minor (O&M) Halyard, Inc.2019-10-10
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (K183356)Weihai Xingtai Packaging Products Co., Ltd.2019-08-19
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted (K181957)Tianchang Jiarui Packaging Material Co., Ltd.2019-07-09
JAMBRO Single Core A Sterilization wrap (K182656)Jiangsu Zhande Medical Supplies Co., Ltd.2019-06-11
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) (K181959)Owens & Minor Halyard, Inc.2019-03-22
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183401)STERIS Corporation2019-03-01
Safe Secure Sterilization Pouches and Rolls (K180139)Safe Secure Packing Co., Ltd.2019-01-03
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K183297)STERIS Corporation2019-01-03
Cardinal Health Sterilization Wrap (K181174)Cardinal Health200, LLC2018-12-11
BH Sterilization Pouch (K172280)Bh Medical Products Co., Ltd.2018-08-03
Sterilization Pouch/Roll Made with Tyvek (K180672)Sigma Medical Supplies Corporation2018-06-06
SIGMA Sterilization Pouch and Roll (K180661)Sigma Medical Supplies Corp.2018-06-05
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K172749)STERIS Corporation2018-02-09
Sterisheet Sterilization Wrap (K170437)Andersen Sterilizers, Inc.2017-11-01
Tyvek Sterilization Pouches with Chevron Seal (K170429)Andersen Sterilizers, Inc.2017-10-27
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator (K162362)Pms Tibbi Cihazlar Teknolojisi San VE Tic AS2017-10-13
Standard Supreme Sterilization Wrapper (K172207)Standard Textile Co., Inc.2017-08-25
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K171533)Ahlstrom Nonwovens, LLC2017-06-29
Gemini Sterilization Wrap (K162993)Medline Industries, Inc.2017-06-23
Self Sealing Sterilization Pouches (K162258)Tianchang Jiarui Packaging Material Co., Ltd.2017-04-28
Cardinal Health Sterilization Wrap (K161910)Cardinal Health200, LLC2017-04-20
SteriTite Containers System & MediTray Products (K161415)Case Medical, Inc.2017-02-10
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator (K160595)Pms Medikal Ambalaj Sanayi VE Ticaret Ltd Sti2016-11-18
Barrier Supreme Sterilization Wrapper (K162162)Standard Textile Co., Inc.2016-11-04
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators (K153540)Safe Secure Packaging Co., Ltd.2016-08-04
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap (K160755)Ahlstrom Nonwovens, LLC2016-07-27
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K160908)STERIS Corporation2016-07-22
Gemini Sterilization Wrap (K152564)Medline Industries, Inc.2016-07-07
Gemini Bonded Sterilization Wrap (K152458)Medline Industries, Inc.2016-06-01
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP) (K152669)Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std2016-01-15
Turbett Surgical Container (K153025)Turbett Surgical, LLC2016-01-14
Cardinal Health Sterilization Wrap (K151445)Cardinal Health200, LLC2015-12-21
Sterisheet Sterilization Wrap (K152291)Andersen Sterilizers, Inc.2015-12-17
Gemini Sterilization Wrap (K150698)Medline Industries, Inc.2015-11-20
Tyvek Sterilization Pouches with Chevron Seal (K152058)Andersen Sterilizers, Inc.2015-11-18
Cardinal Health Sterilization Wrap (K151788)Cardinal Health200, LLC2015-10-30
Wire Sterilization Package with Indicators (K143117)American Orthodontics2015-10-29
U&U Sterilization Pouch and Roll (K143637)U&U Medical Technology Co, Ltd.2015-09-09
Gemini Bonded Sterilization Wrap (K143147)Medline Industries, Inc.2015-05-07
KIMGUARD ONE-STEP Sterilization Wrap (K143053)Kimberly-Clark Health Care2015-04-03
FLASHPAK STERILIZATION CONTAINER SYSTEM (K141826)Symmetry Medical Inc- Manchester2015-04-02
STERILIZATION POUCH/ROLL MADE WITH TYVEK (K133838)Sigma Medical Supplies Corp.2015-03-11
KIMGUARD ONE-STEP Sterilization Wrap (K142782)Kimberly-Clark Health Care2015-03-09
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator (K141693)Advanced Sterilization Products2014-12-19
KIMGUARD ONE STEP STERILIZATION WRAP (K141712)Halyard Health2014-12-18
STERILUCENT SELF-SEAL STERILIZATION POUCH (K141412)Gs Medical Packaging, Inc.2014-12-03
KIMGUARD SMART-FOLD STERILIZATION WRAP (K140963)Kimberly-Clark Corp.2014-11-10
KIMGUARD ONE-STEP STERILIZATION WRAP (K141612)Kimberly-Clark Health Care2014-08-07
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Every clearance here is in the API, with alerts when new ones post.