Atlas FDA

KCT

280 FDA 510(k) clearances · Product code

151 daysmedian time to decision
335 days90th percentile
280clearances measured

FDA profile

Official device name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6850
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 66 · 2021: 26 · 2023: 30 · 2024: 18 · 2025: 50 · 2026: 18
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
SteriBest® Sterilization Tray System (K253187)Mastel Surgical2026-06-18
Straumann® ProClean™ Cassette (041.800 ; 041.801) (K260726)Institut Straumann AG2026-06-03
SteriTite Container System with MediTray Products (K252854)Case Medical, Inc.2026-06-03
PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (K253791)DePuy Mitek, Inc.2026-02-26
Stainless Steel Surgical Kits (K251614)Dentsply Sirona, Inc.2026-02-06
Sterilization Trays (K251756)Paragon Implant Mfg., LLC2025-11-14
Plastic Surgical Kits (K251300)Dentsply Sirona, Inc.2025-07-22
Guided DAS Surgical Kit (K243425)Talladium España, SL2025-07-22
PAL Sterilization Case (K243589)Microaire Surgical Instruments, LLC2025-06-20
Aesculap Aicon® Series Container System (K242762)Aesculap, Inc.2025-05-13
ONE TRAY® Sealed Sterilization Container System (K250029)Innovative Sterilization Technologies2025-05-01
Synthes Graphic Case & Tray System (K241927)Synthes GmbH2025-03-28
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (K242564)Prismatik Dentalcraft, Inc.2025-03-21
Microdent Sterilization Cassette (K242023)Implant Microdent System S.L.U.2025-02-19
NUVENTUS NV.C™ Surgical Cassette and Tray (K243317)Infinitum Eta, Ltd.2025-02-11
System 9 Sterile Battery Container (K242834)Stryker Instruments2025-01-16
Klockner Kits (K243128)SOADCO, S.L.2024-12-18
Guided Surgery Kit Cases (K241492)JJGC Indústria e Comércio de Materiais Dentários S.A.2024-08-23
SteriTite rigid reusable sterilization container with MediTray Products (K240898)Case Medical2024-07-31
CrossRoads Modular Tray System (K241050)Crossroads Extremity Systems2024-07-16
S.I.N. Instrument Kits (K241378)S.I.N. - Sistema DE Implante Nacional S.A.2024-07-12
Perforated Baskets (K231291)Richard Wolf Medical Instruments Corporation2024-06-03
BAHADIR STERILIZATION CONTAINERS (K233578)Bahadir USA, LLC2024-03-22
Washtrays (K231144)Dentsply Sirona2024-01-16
Anthogyr INTEGRAL Guided Surgery Cassettes (K233264)Anthogyr2023-12-22
Aygün Sterilization Container Systems (K233222)Aygun Surgical Instruments Co., Inc.2023-12-12
Instrument Case (K231604)Cochlear Americas2023-08-24
PRO-LITE Sterilization Tray (K231501)STERIS Corporation2023-08-07
Anthogyr Surgical Cassettes (K230680)Anthogyr2023-07-11
Complement Kit Cases (K230804)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-07-07
NobelZygoma PureSet™ Tray (K231219)Nobel Biocare Services AG2023-06-27
Sweden & Martina Surgical Trays (K222640)Sweden & Martina S.P.A.2023-05-26
Neodent Implant System - Helix Short Surgical Kit Cases (K223662)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2023-04-20
Instrument Case P1340904 (K223672)Cochlear2023-03-21
Aesculap AICON Container (K214041)Aesculap, Inc.2022-12-30
S.I.N. Instrument Kits (K222514)S.I.N. – Sistema DE Implante Nacional S.A.2022-10-27
SteriTite Container System with MediTray Parts (K221492)Case Medical, Inc.2022-10-07
S.I.N. Instrument Kits (K222005)S.I.N. - Sistema DE Implante Nacional S.A.2022-09-29
SteriCUBE® Multiple Tray Sterilization Systems (K222328)Stericube, LLC2022-09-28
Surgical and Prosthetic Trays (K220791)Dentsply Sirona2022-05-03
SteriTite Container System with MediTray Products (K212711)Case Medical, Inc.2022-04-29
Neodent Implant System-Helix NGM Compact Surgical Kit Cases (K214051)JJGC Indústria e Comércio de Materiais Dentários S.A.2022-04-13
Surgical Trays (K212281)Dentsply Sirona, Inc.2022-03-04
Southern Implants Instrument Trays (K210923)Southern Implants (Pty), Ltd.2022-03-02
Sterisystem Dry-Base Instrument Tray (K203177)O&M Halyard, Inc.2022-01-02
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device (K213209)K1 Medical, LLC2021-12-28
TCAT TKA Instrument Tray (K203468)THINK Surgical, Inc.2021-12-20
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray (K212932)Nobel Biocare Services AG2021-12-18
InstruSafe Instrument Protection System (K210836)Summitt Medical, LLC2021-11-30
Biotech Dental Kits (K212068)Biotech Dental, Sas2021-11-08
S.I.N. Instrument Kits (K212404)S.I.N. - Sistema DE Implante Nacional S.A.2021-11-03
UroLift System Rigid Retrieval Kit Sterilization Tray (K212396)Neotract, Inc.2021-10-22
Instrument tray, for semi-rigid ureteroscope (K203492)Olympus Winter & Ibe GmbH2021-09-15
Straumann Surgical Cassettes (K203753)Straumann USA, LLC2021-07-29
KARL STORZ Metal Sterilization Trays (K203198)Karl Storz Endoscopy America, Inc.2021-07-06
EZ-TRAXTM Persona Knee Containment Device (K211007)K1 Medical, LLC2021-07-01
Karl Storz Radel Sterilization Trays (K203572)Karl Storz Endoscopy America, Inc.2021-05-07
ST-Z5 (K201878)Z-Systems AG2021-03-25
Neodent EasyGuide Kit Cases (K203618)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-03-09
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes (K201533)Avinent Implant System S.L.U.2021-03-01
KARL STORZ UDEL Sterilization Trays (K201945)Karl Storz Endoscopy America, Inc.2021-02-25
BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit (K201412)Bego Implant Systems GmbH & Co. KG2021-02-18
Standard Sterilizable Tray (K202524)Implant Direct Sybron Manufacturing, LLC2021-01-28
CrossRoads Tray System (K202268)Crossroads Extremity Systems, LLC2020-12-30
EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device (K202270)K1 Medical, LLC2020-12-02
NUVO Implant System – NUVO Instrument Kit Cases (K202515)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2020-11-24
Sweden & Martina Surgical Tray (Model ZSHORTY-INT) (K182084)Sweden & Martina S.P.A.2020-11-04
OsteoMed ExtremiFix Mini & Small System Tray (K202105)Osteomed, LLC2020-10-29
S.I.N. Instrument Kits (K201688)S.I.N. - Sistema DE Implante Nacional S.A.2020-10-21
Mini Sterilizable Tray (K200858)Implant Direct Sybron Manufacturing, LLC2020-08-06
Steripack cases and Tray Systems (K193066)Avalign Technologies, Inc.2020-08-06
Benesta Medical Sterilization Tray (K193603)Caldera Medical, Inc.2020-07-20
UroLift System Procedure Kit Sterilization Tray (K192781)Neotract, Inc.2020-04-14
TCAT TKA Instrument Tray Set (K200632)THINK Surgical, Inc.2020-04-08
JJ Series Container System (K192056)Aesculap, Inc.2020-03-27
SterilContainer S2 System (K193582)Aesculap, Inc.2020-03-17
Avinent Surgical Tray (K191566)Avinent Implant System S.L.U.2020-03-06
EZ-TRAX Containment Device (K192487)K1 Medical, LLC2019-12-23
Neodent Instrument Kit Cases (K190665)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-12-23
Neodent Instrument Kit Cases (K192670)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-12-18
Straumann Modular Cassette (K191522)Institut Straumann AG2019-12-03
Pivot System Sterilization case (K181845)Rp Medical, Inc.2019-11-25
MTS225 and MTS300 Multiple Tray Sterilization Systems (K190541)Pmbs, LLC2019-11-05
Medtronic Transportation / Sterilization Cassettes (K190840)Medtronic Sofamor Danek USA, Inc.2019-10-15
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate (K191475)Nobel Biocare AB2019-08-29
Aesculap® SterilContainer(TM) S2 System (K182414)Aesculap, Inc.2019-07-05
Sonopet iQ Sterilization Tray (K190667)Paragon Medical2019-06-13
DePuy Synthes Sterilization Container System (K181933)Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.2019-05-09
Stryker ChestShield Sterilization Tray System (K183701)Paragon Medical2019-05-07
Neodent Instruments Kits (K182865)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2019-05-07
TCAT (R) THA Instrument Tray Set (K180127)THINK Surgical, Inc.2019-03-15
PRO-LITE Sterilization Tray (K183402)STERIS Corporation2019-03-01
Omni Instrument Tray (K182052)Hologic, Inc.2019-02-26
Endoscope Sterilization Tray (K183139)Intuitive Surgical, Inc.2019-02-01
PRO-LITE Sterilization Tray (K183301)STERIS Corporation2019-01-03
SterilContainer S System (K182032)Aesculap, Inc.2018-12-21
InstruSafe(R) Sterilization Container (K180528)Summit Medical, Inc.2018-11-16
KLOCKNER SURGICAL BOX (K173642)SOADCO, S.L.2018-10-02
Endoscope Sterilization Tray (K180964)Intuitive Surgical, Inc.2018-09-28
PureSet Tray (K181075)Nobel Biocare AB2018-09-27
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