Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cook Incorporated — Predicate Candidate Screening

175 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

225 daysmedian FDA review time

273 days90th percentile

175clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233177	Nest VT Vitrification Device	Cook Incorporated	2024-03-08	162	0
K222254	Gunther Tulip Vena Cava Filter Retrieval Set	Cook Incorporated	2023-05-16	293	0
K223098	Bakri Essential Postpartum Balloon	Cook Incorporated	2022-10-28	28	0
K210734	Endovascular Dilator and Sets	Cook Incorporated	2021-04-06	26	0
K203670	Extra Large Check-Flo Introducer	Cook Incorporated	2021-02-16	62	0
K191498	Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set w	Cook Incorporated	2020-01-29	238	0
K190903	Lawson Retrograde Nephrostomy Wire Puncture Set	Cook Incorporated	2019-12-16	252	0
K193133	Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set	Cook Incorporated	2019-12-12	30	4
K191163	Lumax Guiding Catheter	Cook Incorporated	2019-12-12	225	0
K190084	McLean-Ring Enteral Feeding Tube Set	Cook Incorporated	2019-10-11	267	0
K183323	UPJ Occlusion Balloon Catheter	Cook Incorporated	2019-08-05	248	0
K182985	Roadrunner PC Wire Guide, Olcott Torque Device	Cook Incorporated	2019-07-22	266	4
K183051	Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set	Cook Incorporated	2019-07-16	256	0
K191485	Deflectable Brush Biopsy Set	Cook Incorporated	2019-06-26	22	0
K182832	Cope Pediatric Gastrointestinal Suture Anchor Set, Enterosto	Cook Incorporated	2019-06-26	260	0
K182695	Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ur	Cook Incorporated	2019-06-17	263	0
K182403	Peel-Away Introducer	Cook Incorporated	2019-05-29	267	0
K183035	Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Dis	Cook Incorporated	2019-05-17	197	0
K182252	Cook Unimpregnated Central Venous Catheter	Cook Incorporated	2019-05-17	270	0
K191015	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embr	Cook Incorporated	2019-05-17	30	0
K182231	Brush Biopsy Set ; Deflectable Brush Biopsy Set	Cook Incorporated	2019-05-01	257	0
K182071	Multi-Sideport Catheter Infusion Set	Cook Incorporated	2019-04-25	267	0
K181971	Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy St	Cook Incorporated	2019-04-23	273	0
K182399	Park Blade Septostomy Catheter	Cook Incorporated	2019-04-04	212	0
K181770	Intrauterine Access Balloon Catheter, Selective Salpingograp	Cook Incorporated	2019-03-29	269	0
K181735	Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nep	Cook Incorporated	2019-03-27	268	0
K181722	Polyethylene Catheter	Cook Incorporated	2019-03-22	266	0
K181353	Lunderquist® Fixed Core Wire Guide	Cook Incorporated	2019-02-15	269	0
K181097	Cook Cystostomy Catheter Set	Cook Incorporated	2019-01-18	267	0
K183467	Roadrunner Extra Support Wire Guide	Cook Incorporated	2019-01-11	28	0
K182709	One-Step Suprapubic Introducer	Cook Incorporated	2018-12-26	90	0
K180830	Reuter Tip Deflecting Wire Guide	Cook Incorporated	2018-12-20	265	0
K183036	Dilator Sets	Cook Incorporated	2018-12-20	49	3
K180846	Arterial Pressure Monitoring Set/Tray	Cook Incorporated	2018-12-19	261	1
DEN170055	Retrograde Intubation Set	Cook Incorporated	2018-12-12	443	0
K180792	Arterial Pressure Monitoring Set/Tray	Cook Incorporated	2018-11-30	248	0
K180557	Greene Renal Transplant Stent Set	Cook Incorporated	2018-11-23	267	0
K181757	Günther Tulip® Vena Cava Filter Retrieval Set	Cook Incorporated	2018-11-06	127	0
K182066	O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer S	Cook Incorporated	2018-10-30	90	0
K180286	Polyethylene Catheter	Cook Incorporated	2018-10-26	267	0
K180300	Margolin HSG Cannula, Goldstein Sonohysterography Catheter	Cook Incorporated	2018-10-26	266	0
K180291	Cook Silicone Balloon HSG Catheter	Cook Incorporated	2018-10-26	267	0
K180302	Guardia™ Access Malleable Obturator, Guardia™ Obturator, Sof	Cook Incorporated	2018-10-24	264	0
K180054	Royal Flush Plus High-Flow Catheter	Cook Incorporated	2018-10-05	270	0
K180216	Seidmon Antegrade AQ Stent Set	Cook Incorporated	2018-09-28	246	0
K180029	Malecot Nephrostomy Catheter/Stent Set	Cook Incorporated	2018-09-21	261	0
K180182	Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ur	Cook Incorporated	2018-09-14	234	0
K180053	Sof-Flex Ureteral Stent Set	Cook Incorporated	2018-09-13	248	0
K173657	Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter	Cook Incorporated	2018-08-23	267	0
K181713	Ultraxx Nephrostomy Balloon Catheter Set	Cook Incorporated	2018-08-17	50	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda