Airco/Ohio Medical Products: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Airco/Ohio Medical Products” (first 1979, latest 1984), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BSF | Absorber, Carbon-Dioxide | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| FMZ | Incubator, Neonatal | 1 | 1 |
Review panels
- Anesthesiology (12)
- General Hospital (1)
Most recent Airco/Ohio Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833459 | COAXIAL VOL. VENTILATOR CIRCUIT | BZO | 1984-01-10 | 97 |
| K833452 | OHIO GMS ABSORBER | BSF | 1983-11-29 | 67 |
| K832418 | OHIO TEMPERATURE SIMULATOR | FMZ | 1983-09-12 | 52 |
| K832565 | OHIO 5400 VOLUME MONITOR | BZK | 1983-09-01 | 30 |
| K832185 | OHIO MODEL 922 SPIROMETER | BZG | 1983-08-12 | 37 |
| K830446 | OXYGEN MONITOR OHIO 5100 | CCL | 1983-03-24 | 42 |
| K822456 | OHIO V5A ANESTHESIA VENTILATOR | CBK | 1982-09-21 | 36 |
| K813476 | OHIO VOLUME INCENTIVE SPIROMETER | BWF | 1981-12-31 | 30 |
| K812880 | OHIO NON-REUSABLE TRACHEAL TUBE MAJILL | BTR | 1981-11-24 | 41 |
| K812879 | OHIO NON-REUSABLE TRACHEAL TUBE MURPHY | BTR | 1981-11-24 | 41 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Airco/Ohio Medical Products.
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 Airco/Ohio Medical Products?
FDA lists 13 510(k) clearances under the applicant name “Airco/Ohio Medical Products” (first 1979, latest 1984), across 10 product codes in 2 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 Airco/Ohio Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Airco/Ohio Medical Products is 37 days.
Which FDA product codes appear under Airco/Ohio Medical Products?
The most frequent FDA product codes under this applicant name are BTR (Tube, Tracheal (W/Wo Connector), 3); CBK (Ventilator, Continuous, Facility Use, 2); BSF (Absorber, Carbon-Dioxide, 1).
Next steps
- See all 13 Airco/Ohio Medical Products clearances with predicates and recalls
- Run predicate analysis for product code BTR, Airco/Ohio Medical Products'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.