PJJ
6 FDA 510(k) clearances · Product code
190 daysmedian time to decision
293 days90th percentile
6clearances measured
FDA profile
- Official device name
- Two Or More Sterilant Sterilizer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Medical specialty
- General Hospital
- FDA definition
- Intended for use in terminal sterilization of cleaned, rinsed, and dried metal and non-metal reusable medical devices in health care facilities.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STERIZONE(R) VP4 Sterilizer (K190260) | Tso3, Inc. | 2019-07-19 |
| STERIZONE VP4 Sterilizer (K172191) | Tso3, Inc. | 2018-05-09 |
| STERIZONE VP4 Sterilizer (K173694) | Tso3, Inc. | 2018-03-13 |
| STERIZONE Sterilizer (K153689) | Tso3, Inc. | 2016-06-30 |
| STERIZONE VP4 Sterilizer (K153392) | Ts03, Inc. | 2016-03-24 |
| STERIZONE STERILIZER (K141163) | Tso3, Inc. | 2014-12-17 |
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Every clearance here is in the API, with alerts when new ones post.