Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FLF · Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
260 daysmedian FDA review time
652 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2020-11-12 | 385 | 0 |
| K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2017-10-31 | 260 | 0 |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2015-11-18 | 251 | 0 |
| K142034 | 3M STERI-VAC STERILIZER/AERATOR | 3M Company | 2015-01-08 | 164 | 0 |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2009-12-02 | 267 | 0 |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | Tso3, Inc. | 2006-07-26 | 405 | 0 |
| K020875 | TSO3 OZONE STERILIZER, MODEL 125L | Technologies of Sterilization With Oxone, Tso3, Inc. | 2003-08-26 | 526 | 0 |
| K014013 | H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM | H & W Technology, LLC | 2003-06-25 | 567 | 0 |
| K023290 | STERRAD 50 & STERRAD 100S STERILIZERS | Advanced Sterilization Products | 2003-04-03 | 183 | 9 |
| K923442 | ABTOX PLAZLYTE PROCESS MONITOR | Abtox, Inc. | 1994-12-22 | 892 | 0 |
| K905119 | PLAZLYTE(TM) | Abtox, Inc. | 1994-12-22 | 1499 | 0 |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | 3M Health Care, Ltd. | 1994-12-02 | 238 | 2 |
| K931872 | THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER | American Sterilizer Co. | 1994-02-07 | 299 | 0 |
| K915682 | STERRAD 100 STERILIZATION SYSTEM | Johnson & Johnson Medical, Inc. | 1993-10-01 | 652 | 0 |
| K920930 | MDT/CASTLE 10/90 DUAL LOAD STATION | Mdt Corp., Inc. | 1993-03-31 | 397 | 0 |
| K910649 | MDT/CASTLE 10/90 LOAD STATION | Mdt Biologic Co. | 1991-09-06 | 204 | 0 |
| K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Joslyn Valve Corp. | 1991-03-07 | 360 | 0 |
| K902036 | STERI-VAC GAS STERILIZER MODEL 5XL | 3M Company | 1990-07-19 | 77 | 2 |
| K873200 | KARLSON OZONE STERILIZER MODEL 100B | Life Enhancement Technologies, LLC | 1989-01-27 | 533 | 0 |
| K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | 1985-11-01 | 170 | 0 |
| K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II | Ben Venue Laboratories, Inc. | 1983-12-29 | 85 | 0 |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Amsco Co. | 1983-10-19 | 50 | 0 |
| K821842 | GAS STERILIZATION EQUIPMENT | Getinge International, Inc. | 1982-07-28 | 36 | 0 |
| K820783 | CASTLE MICROCOMPUTER STERILIZER CONTROL | Sybron Corp. | 1982-04-15 | 23 | 0 |
| K812867 | STERI-VAC #400C GAS STERILIZER | 3M Company | 1981-11-02 | 20 | 1 |
| K792660 | 1500 EO EXHAUST HOOD | Castle Co. | 1980-01-29 | 33 | 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