# Cook, Inc.

- Location (FDA's records): Bloomington, IN
- FDA decisions: 371 (1976–2024): 364 510(k) clearances, 1 De Novo grant and 6 original PMA approvals
- Names in FDA's records: Cook, Inc. (195); Cook Incorporated (176)
- Product codes: DQX (26), DQY (22), FGE (22), DYB (20), DQO (15), KRA (14), KRD (13), FOZ (13), FAD (13), LIT (13), LJS (9), LJE (8)
- 510(k) review time since 2016: median 239 days, against 166 for FDA's reviews in the same codes and years (40 of 109 faster)
- Predicates its devices cite: 362 (175 its own); citations of its devices by later devices: 323 (175 its own)
- Recalls linked to its devices: 494 (38 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Urological, Inc.: 18 (https://510kreport.com/company/cook-urological)
- Boston Scientific Corp: 17 (https://510kreport.com/company/boston-scientific)
- Target Therapeutics: 10 (https://510kreport.com/company/target-therapeutics)
- Cook Ob/Gyn: 8 (https://510kreport.com/company/cook-ob-gyn)
- Arrow Intl., Inc.: 7 (https://510kreport.com/company/arrow-intl)
- Terumo Medical Corp.: 6 (https://510kreport.com/company/terumo-medical)
- Van-Tec, Inc.: 5 (https://510kreport.com/company/van-tec)
- Merit Medical Systems, Inc.: 5 (https://510kreport.com/company/merit-medical-systems)

## Firms that cite its devices most
- Cook Ireland, Ltd.: 10 (https://510kreport.com/company/cook-ireland)
- Vidacare Corporation: 4 (https://510kreport.com/company/vidacare)
- Applied Medical Technology, Inc.: 4 (https://510kreport.com/company/applied-medical-technology)
- Cordis Corp.: 4 (https://510kreport.com/company/cordis)
- Argon Medical Devices, Inc.: 4 (https://510kreport.com/company/argon-medical-devices)
- Spectrum Vascular: 4 (https://510kreport.com/company/spectrum-vascular)
- Cook Corporated: 4 (https://510kreport.com/company/cook-corporated)
- Tfx Medical Group: 3 (https://510kreport.com/company/tfx-medical-group)

## Its most-cited devices
- K032869: Cook Coda Balloon Catheter (2003), cited by 9
- K122937: Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR (Product Prefix) (2012), cited by 8
- K901337: Hilal Embolization Microcoil (TM) (1990), cited by 7
- K913258: Disposable Introsseous Infusion Needles (1992), cited by 6
- K002286: Ldob Occlusion Balloon Catheter (2001), cited by 6
- K072625: Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) (2007), cited by 6

## Recent decisions
- K233177: Nest VT Vitrification Device (Mar 8, 2024)
- K222254: Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
- K223098: Bakri Essential Postpartum Balloon (Oct 28, 2022)
- K210734: Endovascular Dilator and Sets (Apr 6, 2021)
- K203670: Extra Large Check-Flo Introducer (Feb 16, 2021)
- K191498: Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (Jan 29, 2020)
- K190903: Lawson Retrograde Nephrostomy Wire Puncture Set (Dec 16, 2019)
- K191163: Lumax Guiding Catheter (Dec 12, 2019)

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