Adven Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Adven Medical” (first 1994, latest 2002), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 160 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 2 | 2 |
| JOW | Sleeve, Limb, Compressible | 2 | 2 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 1 |
| KBG | Trocar, Sinus | 1 | 1 |
Review panels
Most recent Adven Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021528 | REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP | JOW | 2002-08-21 | 103 |
| K013987 | REPROCESSED DISPOSABLE TROCARS | KBG | 2002-03-01 | 87 |
| K012675 | REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS | JOW | 2002-02-12 | 182 |
| K012694 | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | HWE | 2002-02-04 | 174 |
| K012676 | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | HWE | 2002-02-04 | 174 |
| K940501 | RE-SHARPENABLE SAW BLADES | GFA | 1994-06-28 | 146 |
Recalls
openFDA lists no recalls under a recalling firm named Adven 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 Adven Medical?
FDA lists 6 510(k) clearances under the applicant name “Adven Medical” (first 1994, latest 2002), across 4 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 Adven Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Adven Medical is 160 days.
Which FDA product codes appear under Adven Medical?
The most frequent FDA product codes under this applicant name are HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, 2); JOW (Sleeve, Limb, Compressible, 2); GFA (Blade, Saw, General & Plastic Surgery, Surgical, 1).
Next steps
- See all 6 Adven Medical clearances with predicates and recalls
- Run predicate analysis for product code HWE, Adven 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.