V. Mueller O.V. Baxter Healthcare Corp.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “V. Mueller O.V. Baxter Healthcare Corp.” (first 1976, latest 1981), across 26 product codes in 7 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 3 | 3 |
| FDC | Resectoscope, Working Element | 3 | 3 |
| HNC | Specula, Ophthalmic | 3 | 3 |
| HNF | Scissors, Ophthalmic | 3 | 3 |
| HNN | Knife, Ophthalmic | 3 | 3 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 3 | 3 |
| DWS | Instruments, Surgical, Cardiovascular | 2 | 2 |
| FEC | Obturator, For Endoscope | 2 | 2 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
Plus 16 more product codes.
Review panels
- Gastroenterology and Urology (21)
- Ophthalmic (10)
- General and Plastic Surgery (4)
- Cardiovascular (2)
- Ear, Nose and Throat (2)
- Anesthesiology (1)
- General Hospital (1)
Most recent V. Mueller O.V. Baxter Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K803292 | FIELD SUCTION DISSECTOR | GDI | 1981-01-29 | 30 |
| K792383 | KELMAN DIPSTICK | HOE | 1979-12-11 | 15 |
| K771197 | NORTON ENDOTRACHEAL | BTR | 1977-08-16 | 46 |
| K771302 | PFISTER-SCHWARTZ STONE RETRIEVER | FGO | 1977-08-02 | 18 |
| K770959 | BOUGIE, FILIFORM, JACKSON | KBI | 1977-06-14 | 18 |
| K770280 | CORD, ELECTROSURGICAL-STERILE & DISPOS. | KNS | 1977-04-15 | 60 |
| K760851 | CONVERSE ALTAR RETRACTOR | KAL | 1977-03-10 | 146 |
| K761242 | TEFLON COATED RESECTOSCOPE SHEATH | FJL | 1976-12-16 | 3 |
| K760273 | LITHOTRITE | FGK | 1976-12-06 | 137 |
| K760189 | STOPCOCK, WATERLINE | FAJ | 1976-12-02 | 149 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named V. Mueller O.V. Baxter Healthcare 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 V. Mueller O.V. Baxter Healthcare Corp.?
FDA lists 41 510(k) clearances under the applicant name “V. Mueller O.V. Baxter Healthcare Corp.” (first 1976, latest 1981), across 26 product codes in 7 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 V. Mueller O.V. Baxter Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name V. Mueller O.V. Baxter Healthcare Corp. is 35 days.
Which FDA product codes appear under V. Mueller O.V. Baxter Healthcare Corp.?
The most frequent FDA product codes under this applicant name are FAJ (Cystoscope And Accessories, Flexible/Rigid, 3); FDC (Resectoscope, Working Element, 3); HNC (Specula, Ophthalmic, 3).
Next steps
- See all 41 V. Mueller O.V. Baxter Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, V. Mueller O.V. Baxter Healthcare 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.