O-Two Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “O-Two Medical Technologies, Inc.” (first 2005, latest 2018), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 138 days. 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 | 1 | 137 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 276 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 331 |
| 2019 | 0 | — |
| 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 O-Two Medical Technologies, Inc. took a median 331 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 222 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 5 | 5 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
Review panels
- Anesthesiology (8)
Most recent O-Two Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173205 | Equinox Advantage | BZR | 2018-08-29 | 331 |
| K141595 | O-TWO E700,O-TWO E600,O-TWO E500 | BTL | 2015-03-16 | 276 |
| K113687 | EQUINOX RELIEVE | BZR | 2012-04-30 | 137 |
| K112546 | O_TWO CPAP SYSTEM | BYE | 2011-12-27 | 117 |
| K093862 | CAREVENT HANDHELD CPAP SYSTEM | BTL | 2010-05-06 | 140 |
| K081330 | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) | BTL | 2009-03-06 | 298 |
| K051469 | CAREVENT ATV+ AND CAREVENT MRI | BTL | 2005-09-28 | 117 |
| K051889 | CAREVENT CA AND DRA | BTL | 2005-08-30 | 49 |
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2019-02-12.
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.
- O-Two Systems Intl., Inc. (14 510(k)s)
- O-Two Systems International, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under O-Two Medical Technologies, Inc.?
FDA lists 8 510(k) clearances under the applicant name “O-Two Medical Technologies, Inc.” (first 2005, latest 2018), across 3 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 O-Two Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name O-Two Medical Technologies, Inc. is 138 days.
Which FDA product codes appear under O-Two Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are BTL (Ventilator, Emergency, Powered (Resuscitator), 5); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1).
Next steps
- See all 8 O-Two Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTL, O-Two Medical Technologies, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.