Oximetrix, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Oximetrix, Inc.” (first 1976, latest 1986), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| DQE | Catheter, Oximeter, Fiber-Optic | 3 | 3 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Oximetrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K853018 | MODEL 3000 OPTICATH COMPUTER | DXG | 1986-01-13 | 180 |
| K842622 | HEMO STATIC/ESU SCALPEL SYSTEM | GEI | 1984-10-23 | 110 |
| K833966 | PUMP INFUSION WEARABLE INFUSION PUMP | JSJ | 1984-01-25 | 70 |
| K823007 | OPTICATH HEPARIN COATED, FLOW-DIRECT | DYG | 1982-11-01 | 20 |
| K821057 | FLOW DIRECTED THERMAL-DILUTION INFUSION | DYG | 1982-05-18 | 32 |
| K821056 | FLOW DIRECTED THERMAL-DILUTION CATHETER | — | 1982-05-18 | 33 |
| K820674 | OPTICATH | DQE | 1982-03-25 | 14 |
| K811391 | OXIMETRIX ACCU SAT CPB | DRY | 1981-07-20 | 63 |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | GEI | 1980-01-04 | 106 |
| K781879 | HEATER, OXIMETER SYSTEM | DQA | 1979-01-08 | 63 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Oximetrix, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Oximetrix, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Oximetrix, Inc.” (first 1976, latest 1986), across 8 product codes in 4 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 Oximetrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oximetrix, Inc. is 52 days.
Which FDA product codes appear under Oximetrix, Inc.?
The most frequent FDA product codes under this applicant name are DQE (Catheter, Oximeter, Fiber-Optic, 3); DYG (Catheter, Flow Directed, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 12 Oximetrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQE, Oximetrix, 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.