O-Two Systems Intl., Inc.: FDA clearances and approvals
O-Two Systems Intl., Inc. has 14 FDA 510(k) clearances (first 1983, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time: 47 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 7 | 7 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 3 | 3 |
| CBP | Valve, Non-Rebreathing | 3 | 3 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
Review panels
- Anesthesiology (14)
Most recent O-Two Systems Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991195 | CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV | BTL | 1999-04-22 | 14 |
| K983857 | AUTOVENT 1500 | BTL | 1998-11-04 | 2 |
| K983785 | AUTOVENT 1000 | BTL | 1998-10-29 | 2 |
| K983705 | EMT RESUSCITATOR | BTL | 1998-10-29 | 8 |
| K983643 | GENESIS BLS | BTL | 1998-10-29 | 13 |
| K960995 | CPR BIO-BARRIER FACESHEILD | CBP | 1997-01-07 | 301 |
| K940712 | PPM III | CBP | 1994-11-14 | 270 |
| K940927 | RESCUE BREATHER | CBP | 1994-10-14 | 228 |
| K932170 | FLYNNR GENESIS II A/C, A/O AND IDLH | BTL | 1993-10-25 | 174 |
| K922810 | ODYSSEY | BTM | 1993-01-22 | 226 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named O-Two Systems Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does O-Two Systems Intl., Inc. have?
O-Two Systems Intl., Inc. has 14 FDA 510(k) clearances (first 1983, latest 1999), across 4 product codes in 1 review panel.
How long does FDA take to clear O-Two Systems Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across O-Two Systems Intl., Inc.'s cleared 510(k)s is 47 days.
What devices does O-Two Systems Intl., Inc. make?
Its most frequent FDA product codes are BTL (Ventilator, Emergency, Powered (Resuscitator), 7); BTM (Ventilator, Emergency, Manual (Resuscitator), 3); CBP (Valve, Non-Rebreathing, 3).
Has O-Two Systems Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching O-Two Systems Intl., Inc. Related entities may recall under other names.
Next steps
- See all 14 O-Two Systems Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTL, O-Two Systems Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.