Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FLE — Predicate Candidate Screening
185 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
395 days90th percentile
185clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | 2026-06-24 | 85 | 0 |
| K260254 | Enbio PRO | Enbio Group AG | 2026-02-26 | 30 | 0 |
| K252307 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH (A Getinge Group Company) | 2026-01-22 | 182 | 0 |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025-12-30 | 343 | 0 |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2025-08-14 | 205 | 0 |
| K243994 | Steam Sterilizer (2545D) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 | 162 | 0 |
| K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | 2025-03-07 | 86 | 0 |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corporation | 2024-04-04 | 195 | 0 |
| K233504 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2024-02-08 | 100 | 0 |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023-12-19 | 83 | 0 |
| K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 | 88 | 0 |
| K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023-09-13 | 28 | 0 |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | 2023-06-21 | 29 | 0 |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. | 2023-05-05 | 133 | 0 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 | 266 | 0 |
| K213545 | Steelco VS Series Steam Sterilizers, models 262839, 262851, | Steelco S.P.A. | 2023-02-02 | 451 | 0 |
| K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 387 | Tuttnauer , Ltd. | 2022-12-16 | 109 | 0 |
| K220102 | MOST-T Autoclave | Shinva Medical Instrument Co., Ltd. | 2022-10-12 | 273 | 0 |
| K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 669 | Tuttnauer , Ltd. | 2022-09-20 | 145 | 0 |
| K213758 | Lexa PLUS RIS-311 | W&H Sterilization S.R.L. | 2022-08-19 | 262 | 0 |
| K220736 | Consolidated HC Steam Sterilizer | Consolidated Machine Corp. | 2022-08-01 | 140 | 0 |
| K214120 | GSS610N21 Series Steam Sterilizer | Maquet GmbH | 2022-05-18 | 139 | 0 |
| K214057 | STATIM 6000B Vacuum Autoclave | Scican , Ltd. | 2022-03-31 | 94 | 0 |
| K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, | Fort Defiance Industries, LLC | 2022-03-02 | 126 | 0 |
| K213991 | Enbio S | Enbio Group AG | 2022-02-22 | 63 | 0 |
| K213080 | T-Edge 10, T-Edge 11 | Tuttnauer , Ltd. | 2022-01-04 | 103 | 0 |
| K210279 | Enbio S | Enbio Group AG | 2021-10-29 | 270 | 0 |
| K212424 | AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam St | STERIS Corporation | 2021-10-28 | 85 | 0 |
| K211500 | AMSCO 600 Medium Steam Sterilizer | STERIS Corporation | 2021-08-25 | 103 | 0 |
| K210326 | Bravo G4 Chamber Autoclave | Scican , Ltd. | 2021-07-01 | 147 | 0 |
| K201927 | Getinge GSS610N Series Steam Sterilizer | Maquet GmbH | 2021-03-01 | 234 | 0 |
| K203061 | Amsco Evolution Medium Steam Sterilizer (Models HC-900 and H | STERIS Corporation | 2020-11-06 | 29 | 0 |
| K192910 | STATClave G4 Chamber Autoclave | Scican , Ltd. | 2020-06-19 | 248 | 1 |
| K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA- | Sturdy Industrial Co., Ltd. | 2019-11-01 | 463 | 0 |
| K191896 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2019-10-31 | 108 | 0 |
| K190062 | STATCLAVE G4 Chamber Autoclave | Scican , Ltd. | 2019-07-26 | 192 | 1 |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 6 | Tuttnauer , Ltd. | 2019-07-08 | 399 | 0 |
| K183410 | AMSCO 600 Steam Sterilizer | STERIS Corporation | 2019-03-27 | 107 | 0 |
| K180272 | Saniclave 250 | Revolutionary Science | 2018-07-26 | 176 | 0 |
| K172825 | MN-111 | W&H Sterilization S.R.L. | 2018-05-30 | 254 | 0 |
| K173481 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018-03-09 | 116 | 0 |
| K170304 | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers | Astell Scientific Limited | 2018-03-02 | 395 | 0 |
| K173493 | Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC- | STERIS Corporation | 2018-02-23 | 102 | 0 |
| K173485 | Amsco Evolution Medium Steam Sterilizer | STERIS Corporation | 2018-02-22 | 101 | 0 |
| K173490 | Amsco Evolution Medium Steam Sterilizer (Models HC-800 and H | STERIS Corporation | 2018-02-22 | 101 | 0 |
| K172159 | Getinge GSS67N Series Steam Sterilizer | Maquet GmbH | 2018-01-30 | 196 | 0 |
| K163337 | Midmark and Ritter M9 and M11 UltraClave® Automatic Steriliz | Midmark Corporation | 2017-08-31 | 276 | 0 |
| K170228 | Belimed Steam Sterilizer MST-H TOP 5000 | Belimed AG | 2017-05-12 | 107 | 0 |
| K161848 | Family of Steam sterilizers B17 B22 Series | Cefla S.C. | 2017-02-23 | 233 | 0 |
| K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016-03-04 | 266 | 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