Inovo, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Inovo, Inc.” (first 2003, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 92 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 109 |
| 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | 5 | 5 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Inovo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141967 | PUREFILL OXYGEN COMPRESSOR | CAW | 2014-11-07 | 109 |
| K113111 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION | NFB | 2011-12-08 | 49 |
| K103392 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER | NFB | 2010-12-17 | 28 |
| K060751 | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR | NFB | 2006-07-18 | 119 |
| K051540 | INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR | NFB | 2005-09-21 | 103 |
| K031983 | INOVO, INC, ECONOMIZER CONSERVING REGULATOR | NFB | 2003-09-15 | 81 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-04-26.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Inovo, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Inovo, Inc.” (first 2003, latest 2014), across 2 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 Inovo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inovo, Inc. is 92 days.
Which FDA product codes appear under Inovo, Inc.?
The most frequent FDA product codes under this applicant name are NFB (Conserver, Oxygen, 5); CAW (Generator, Oxygen, Portable, 1).
Next steps
- See all 6 Inovo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NFB, Inovo, 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.