Omnicon Medical Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Omnicon Medical Corp.” (first 1976, latest 1983), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 15 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 | 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 5 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| EWC | Chamber, Acoustic (For Audiometric Testing) | 1 | 1 |
| FMP | Protector, Skin Pressure | 1 | 1 |
Review panels
Most recent Omnicon Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823872 | EMERGENCY TRACHEOSTOMY KIT | EWC | 1983-01-21 | 25 |
| K820577 | ANESTHESIA BACTERIA FILTER | CAH | 1982-03-18 | 15 |
| K820576 | MAINFLOW BACTERIA FILTER | CAH | 1982-03-18 | 15 |
| K801804 | ANESTHESIA BACTERIA FILTER | CAH | 1980-08-13 | 15 |
| K801803 | MAINFLOW BACTERIA FILTER | CAH | 1980-08-13 | 15 |
| K772060 | PROTECT IV GARD | FMP | 1977-12-20 | 50 |
| K770136 | DISPOSABLE BACTERIA FILTER | CAH | 1977-02-14 | 21 |
| K770001 | AIRWAY, BERMAN 40, 60, 80, 90, L00MM'S | CAE | 1977-01-12 | 9 |
| K760819 | CONDUCTIVE ANESTHESIA BREATHING CIRCUIT | CAI | 1976-10-27 | 15 |
| K760149 | CONDUCTIVE ANESTHSIA BREATH. CIRCUIT | CAI | 1976-07-19 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Omnicon Medical Corp..
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 Omnicon Medical Corp.?
FDA lists 10 510(k) clearances under the applicant name “Omnicon Medical Corp.” (first 1976, latest 1983), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omnicon Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnicon Medical Corp. is 15 days.
Which FDA product codes appear under Omnicon Medical Corp.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 5); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 2); CAE (Airway, Oropharyngeal, Anesthesiology, 1).
Next steps
- See all 10 Omnicon Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAH, Omnicon Medical Corp.'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.