Invictus Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Invictus Medical, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|
| 2015 | 1 | 88 |
| 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | 1 | 1 |
| QWX | Active Noise Attenuation System For Infant Incubators | 1 | 0 |
Review panels
- General Hospital (2)
Most recent Invictus Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150243 | Invictus Medical GelShield | FMP | 2015-05-01 | 88 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220048 | De Novo | Active Noise Attenuation System For Infant Incubators | 2023-06-16 |
Recalls
openFDA lists no recalls under a recalling firm named Invictus Medical, 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.
- Invictus Lighting (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invictus Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Invictus Medical, Inc.” (first 2015, latest 2015), plus 1 De Novo decision, 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 Invictus Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invictus Medical, Inc. is 88 days.
Which FDA product codes appear under Invictus Medical, Inc.?
The most frequent FDA product codes under this applicant name are FMP (Protector, Skin Pressure, 1); QWX (Active Noise Attenuation System For Infant Incubators, 1).
Next steps
- See all 1 Invictus Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMP, Invictus Medical, 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.