Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRG — Predicate Candidate Screening
323 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
278 days90th percentile
323clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Tec | O&M Halyard, Inc. | 2026-07-02 | 27 | 0 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | 2026-05-28 | 266 | 0 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* | O&M Halyard, Inc. | 2026-05-18 | 227 | 0 |
| K251347 | Sterilization Pouch/Roll | Sterivic Medical Co., Ltd. | 2026-01-28 | 273 | 0 |
| K251177 | Self-Seal Sterilization Pouch and Roll | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 | 240 | 0 |
| K250306 | Chex-All Sterilization Pouches and Tubes | Propper Manufacturing Co., Inc. | 2025-10-31 | 270 | 0 |
| K243179 | Sterilization Pouch and Roll | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 | 269 | 0 |
| K250321 | GCI Sterilization Wrappers | George Courey, Inc. | 2025-06-06 | 122 | 0 |
| K243721 | Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 | 143 | 0 |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical I | Turbett Surgical | 2025-04-04 | 92 | 0 |
| K241565 | Sterilization Package/Reel | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 | 269 | 0 |
| K243431 | Medicom Sterilization Pouch and Reel | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 | 108 | 0 |
| K242898 | Sterilization Pouches and Reels | Shanghai Jianzhong Medical Packaging Co., Ltd. | 2025-02-21 | 151 | 0 |
| K240438 | CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® S | Comercializadora Brever | 2024-11-04 | 264 | 0 |
| K242839 | Safe Secure Sterilization Pouches and Rolls | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2024-10-16 | 27 | 0 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P60 | Primed Medical Products, Inc. | 2024-10-07 | 70 | 0 |
| K241123 | Perpak™ Sterilization Tyvek Pouch | Km Corp. | 2024-09-18 | 148 | 0 |
| K234132 | Medline Reusable Sterilization Wrappers | Medline Industries, LP | 2024-09-17 | 264 | 0 |
| K234050 | HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® | O&M Halyard, Inc. | 2024-09-16 | 270 | 0 |
| K240330 | HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMA | O&M Halyard, Inc. | 2024-08-07 | 184 | 0 |
| K240862 | Medicom Sterilization Wrap | Medicom Group, Inc. | 2024-06-21 | 85 | 0 |
| K232625 | Steriking® Pouch for Robotic Instruments | Wipak OY | 2024-06-07 | 283 | 0 |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P60 | Primed Medical Products, Inc. | 2024-05-24 | 182 | 0 |
| K233262 | Dukal SMS Sterilization Wrap | Dukal, LLC | 2024-03-22 | 175 | 0 |
| K230137 | Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC | 2023-12-07 | 323 | 0 |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | 2023-09-07 | 64 | 0 |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak OY | 2023-09-07 | 64 | 0 |
| K223600 | Sterilization Wrap | Wuhan Zonsen Medical Products Co., Ltd. | 2023-08-25 | 266 | 0 |
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | 2023-08-07 | 75 | 0 |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. | 2023-05-09 | 222 | 0 |
| K222151 | Sterilization Wrap | Kenpax International Limited | 2023-03-23 | 246 | 0 |
| K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | 2023-02-13 | 230 | 0 |
| K221379 | Steriking LT-Blueline Pouches with Tyvek | Wipak OY | 2023-01-04 | 237 | 0 |
| K221377 | SteriKing LT-Blueline Pouches with Tyvek | Wipak OY | 2022-12-22 | 224 | 0 |
| K220365 | Gemini Sterilization Wrap | Medline Industries, LP | 2022-10-06 | 240 | 0 |
| K222440 | Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO- | Steris | 2022-09-09 | 28 | 0 |
| K191131 | Solidence Multipockets | Solidence Surgical Corporation | 2022-08-03 | 1192 | 0 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Ste | Owens & Minor (O&M) Halyard, Inc. | 2022-07-27 | 217 | 0 |
| K221016 | Steriking Packaging for Medical Devices | Wipak OY | 2022-05-05 | 30 | 0 |
| K213907 | CareGUARD Sterilization Wrap | Care Essentials Pty, Ltd. | 2022-03-14 | 90 | 0 |
| K220133 | Sterilization Wraps | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-03-10 | 51 | 0 |
| K210810 | Steiking Packaging for Medical Devices | Wipak OY | 2022-01-23 | 312 | 0 |
| K212338 | SterileRight sterilization pouch and roll | Sterileright Packaging Mfg., Inc. | 2021-11-01 | 97 | 0 |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021-10-22 | 100 | 0 |
| K202593 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2021-05-19 | 253 | 0 |
| K202462 | SIGMA Sterilization Pouch and Roll | Sigma Medical Supplies Corporation | 2021-04-23 | 239 | 0 |
| K200336 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | 2020-11-12 | 275 | 0 |
| K200335 | Sterisheet Sterilization Wrap | Andersen Sterilizers, Inc. | 2020-11-12 | 275 | 0 |
| K200240 | Turbett Instrument Pod | Turbett Surgical, Inc. | 2020-04-30 | 90 | 0 |
| K193561 | Diposable Medical Device Self-seal Sterilization Pouch, Disp | Weihai Xingtai Packaging Products Co., Ltd. | 2020-04-15 | 114 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda