Oxequip Health Ind.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oxequip Health Ind.” (first 1979, latest 1983), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| DRM | Compressor, Cardiac, External | 1 | 1 |
| JXL | Block, Bite | 1 | 1 |
Review panels
- Anesthesiology (3)
- Cardiovascular (1)
- Neurology (1)
Most recent Oxequip Health Ind. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K833496 | OXYGEN MONITOR/CONTROLLER | CCL | 1983-12-16 | 70 |
| K812624 | OXEQUIP CONDUCTIVE & NON ANES. BREATH | CAI | 1981-10-26 | 41 |
| K811987 | OXY-QUIK MARK IV OXYGEN INHALATOR | DRM | 1981-07-27 | 14 |
| K800369 | TRI PAC MOUTH PROP | JXL | 1980-02-28 | 8 |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | CCL | 1979-12-04 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Oxequip Health Ind..
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 Oxequip Health Ind.?
FDA lists 5 510(k) clearances under the applicant name “Oxequip Health Ind.” (first 1979, latest 1983), across 4 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 Oxequip Health Ind.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxequip Health Ind. is 14 days.
Which FDA product codes appear under Oxequip Health Ind.?
The most frequent FDA product codes under this applicant name are CCL (Analyzer, Gas, Oxygen, Gaseous-Phase, 2); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1); DRM (Compressor, Cardiac, External, 1).
Next steps
- See all 5 Oxequip Health Ind. clearances with predicates and recalls
- Run predicate analysis for product code CCL, Oxequip Health Ind.'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.