Tso3, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Tso3, Inc.” (first 2006, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 188 days. Since 2017 the median was 161 days, against 117 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 187 |
| 2015 | 0 | — |
| 2016 | 1 | 190 |
| 2017 | 0 | — |
| 2018 | 2 | 198 |
| 2019 | 1 | 161 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tso3, Inc. took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PJJ | Two Or More Sterilant Sterilizer | 5 | 5 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
Review panels
- General Hospital (10)
Most recent Tso3, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190260 | STERIZONE(R) VP4 Sterilizer | PJJ | 2019-07-19 | 161 |
| K172191 | STERIZONE VP4 Sterilizer | PJJ | 2018-05-09 | 293 |
| K173694 | STERIZONE VP4 Sterilizer | PJJ | 2018-03-13 | 102 |
| K153689 | STERIZONE Sterilizer | PJJ | 2016-06-30 | 190 |
| K141698 | STERIZONE CHEMICAL INDICATOR | JOJ | 2014-12-17 | 176 |
| K141580 | STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR | FRC | 2014-12-17 | 187 |
| K141163 | STERIZONE STERILIZER | PJJ | 2014-12-17 | 226 |
| K090636 | TSO3 OZONE STERILIZER, MODEL 125L | FLF | 2009-12-02 | 267 |
| K080198 | TSO3 OZONE STERILIZATION WRAP | FRG | 2008-05-30 | 126 |
| K051595 | TSO3 OZONE STERILIZER, MODEL 125L | FLF | 2006-07-26 | 405 |
Recalls
openFDA lists no recalls under a recalling firm named Tso3, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tso3 Inc., Now A Part of Stryker (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tso3, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Tso3, Inc.” (first 2006, latest 2019), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tso3, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tso3, Inc. is 188 days. Since 2017: 161 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tso3, Inc.?
The most frequent FDA product codes under this applicant name are PJJ (Two Or More Sterilant Sterilizer, 5); FLF (Sterilizer, Ethylene-Oxide Gas, 2); FRC (Indicator, Biological Sterilization Process, 1).
Next steps
- See all 10 Tso3, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PJJ, Tso3, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.