Promex, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Promex, Inc.” (first 1994, latest 2002), across 11 product codes in 8 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | 5 | 5 |
| FCG | Biopsy Needle | 4 | 4 |
| DYB | Introducer, Catheter | 1 | 1 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| GDF | Guide, Needle, Surgical | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| MIA | Needle, Spinal, Short Term | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (8)
- Gastroenterology and Urology (4)
- Anesthesiology (1)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
- Ophthalmic (1)
- Orthopedic (1)
- Radiology (1)
Most recent Promex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023450 | BIOPSY SITE TISSUE MARKER DEVICE | NEU | 2002-12-19 | 65 |
| K022634 | CO-AXIAL INTRODUCER NEEDLE | DYB | 2002-11-06 | 90 |
| K010400 | VACUUM ASSISTED CORE BIOPSY DEVICE | KNW | 2001-07-24 | 162 |
| K011270 | AUTOMATED CORE BIOPSY DEVICE | FCG | 2001-06-22 | 57 |
| K001132 | BONE BIOPSY NEEDLE | KNW | 2000-05-01 | 21 |
| K994272 | AUTOMATED CORE BIOPSY DEVICE | KNW | 2000-01-07 | 18 |
| K993435 | MANUAL BONE MARROW BIOPSY DEVICE | KNW | 1999-12-06 | 55 |
| K973184 | PROSTATE SEEDING NEEDLE | IWJ | 1997-11-21 | 88 |
| K972865 | PROMEX ENT TISSUE REMOVAL SYSTEM | ERL | 1997-09-29 | 56 |
| K961078 | AUTOMATED VITRECTOMY DEVICE | HQE | 1996-06-14 | 88 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Promex, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Promex, Inc. (a text match, not an official crosswalk):
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.
- Promex Technologies, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Promex, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Promex, Inc.” (first 1994, latest 2002), across 11 product codes in 8 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 Promex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Promex, Inc. is 56 days.
Which FDA product codes appear under Promex, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 5); FCG (Biopsy Needle, 4); DYB (Introducer, Catheter, 1).
Next steps
- See all 18 Promex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Promex, 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.