# Promex, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 18 (1994–2002): 18 510(k) clearances
- Product codes: KNW (5), FCG (4), DYB (1), MIA (1), JDW (1), GDF (1), NEU (1), IWJ (1), ERL (1), HQE (1), GEI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 17 (0 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Pneumrx, Inc.: 3 (https://510kreport.com/company/pneumrx)
- Carbon Medical Technologies, Inc.: 2 (https://510kreport.com/company/carbon-medical-technologies)
- Nico Corporation: 2 (https://510kreport.com/company/nico)
- Acueity, Inc.: 1 (https://510kreport.com/company/acueity)
- Bip USA, Inc.: 1 (https://510kreport.com/company/bip-usa)
- Storz Instrument Co.: 1 (https://510kreport.com/company/storz-instrument)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Promex Technologies, LLC: 1 (https://510kreport.com/company/promex-technologies)

## Its most-cited devices
- K994272: Automated Core Biopsy Device (2000), cited by 3
- K022634: CO-Axial Introducer Needle (2002), cited by 2
- K023450: Biopsy Site Tissue Marker Device (2002), cited by 2
- K011270: Automated Core Biopsy Device (2001), cited by 2
- K001132: Bone Biopsy Needle (2000), cited by 2
- K954231: Augastroenterology-Urology Biopsy Instrument (1995), cited by 1

## Recent decisions
- K023450: Biopsy Site Tissue Marker Device (Dec 19, 2002)
- K022634: CO-Axial Introducer Needle (Nov 6, 2002)
- K010400: Vacuum Assisted Core Biopsy Device (Jul 24, 2001)
- K011270: Automated Core Biopsy Device (Jun 22, 2001)
- K001132: Bone Biopsy Needle (May 1, 2000)
- K994272: Automated Core Biopsy Device (Jan 7, 2000)
- K993435: Manual Bone Marrow Biopsy Device (Dec 6, 1999)
- K973184: Prostate Seeding Needle (Nov 21, 1997)

Source page: https://510kreport.com/company/promex