Maxxim Medical: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Maxxim Medical” (first 1994, latest 2002), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 10 | 10 |
| LZA | Polymer Patient Examination Glove | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
Plus 4 more product codes.
Review panels
- General Hospital (18)
- Cardiovascular (5)
- General and Plastic Surgery (3)
- Neurology (1)
- Physical Medicine (1)
Most recent Maxxim Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | 2002-11-12 | 46 |
| K021452 | STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE | LZA | 2002-08-01 | 87 |
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES | DQX | 2001-08-28 | 70 |
| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | DYB | 2001-05-31 | 260 |
| K011198 | SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL | LZA | 2001-05-17 | 28 |
| K010297 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) | LZA | 2001-02-16 | 16 |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | 2000-10-19 | 29 |
| K001343 | EUDERMIC PF POWDER-FREE SURGICAL GLOVES | KGO | 2000-06-12 | 46 |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | DQO | 1999-12-21 | 336 |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | LYZ | 1999-10-13 | 49 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Maxxim Medical.
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 Maxxim Medical?
FDA lists 28 510(k) clearances under the applicant name “Maxxim Medical” (first 1994, latest 2002), across 14 product codes in 5 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 Maxxim Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Maxxim Medical is 88 days.
Which FDA product codes appear under Maxxim Medical?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 10); LZA (Polymer Patient Examination Glove, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 28 Maxxim Medical clearances with predicates and recalls
- Run predicate analysis for product code KGO, Maxxim Medical'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.