Axiom Medical, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Axiom Medical, Inc.” (first 1977, latest 2000), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | 3 | 3 |
| GBX | Catheter, Irrigation | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 2 | 2 |
| KDC | Instrument, Surgical, Disposable | 2 | 2 |
| BZW | Stethoscope, Esophageal | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DSS | Clip, Vascular | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| ENW | Catheter, Nasopharyngeal | 1 | 1 |
Plus 9 more product codes.
Review panels
- General and Plastic Surgery (12)
- Gastroenterology and Urology (4)
- Anesthesiology (3)
- Cardiovascular (3)
- General Hospital (2)
- Ear, Nose and Throat (1)
Most recent Axiom Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993592 | AXIOM MULTIPURPOSE WOUND DRAIN | BSO | 2000-05-17 | 208 |
| K971851 | INTERPLEURAL ANESTHESIA CATHETER | BSO | 1998-01-22 | 247 |
| K965146 | FLAT CLOSED WOUND DRAIN WITH TROCAR | GBX | 1997-03-10 | 77 |
| K934895 | GLASSMAN SILICONE CATHETER | EZL | 1994-10-13 | 373 |
| K922760 | ATRAUM WOUND DRESSING--MODIFICATION | KMF | 1992-10-30 | 155 |
| K905422 | PVC ROUND WOUND DRAINS | GBX | 1991-02-11 | 69 |
| K904218 | SUCTION SYSTEM | GEA | 1990-10-31 | 49 |
| K904133 | DISPOSABLE FLUID COLLECTION BAG | GBX | 1990-10-11 | 35 |
| K863247 | AXIOM TROCAR THORACIC CATHETER | GBS | 1986-08-29 | 7 |
| K861306 | SUCTION SYSTEM | GEA | 1986-06-09 | 62 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Axiom Medical, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Axiom, Inc. (4 510(k)s)
- Axiom Usa., Inc. (4 510(k)s)
- Axiom Worldwide, Inc. (4 510(k)s)
- Axiom Manufacturing (2 510(k)s)
- Axiom Ent. Co., Ltd. (1 510(k)s)
- Axiom Orthopaedics, Inc. (1 510(k)s)
- Axiom Technology Partners, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Axiom Medical, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Axiom Medical, Inc.” (first 1977, latest 2000), across 19 product codes in 6 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 Axiom Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axiom Medical, Inc. is 68 days.
Which FDA product codes appear under Axiom Medical, Inc.?
The most frequent FDA product codes under this applicant name are GBS (Catheter, Ventricular, General & Plastic Surgery, 3); GBX (Catheter, Irrigation, 3); BSO (Catheter, Conduction, Anesthetic, 2).
Next steps
- See all 28 Axiom Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GBS, Axiom Medical, 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, 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.