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

Cook, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

301 days90th percentile

190clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133130	BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE	Cook, Inc.	2015-01-09	466	2
K140593	ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE	Cook, Inc.	2014-12-15	283	0
K132592	FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET	Cook, Inc.	2014-10-09	416	0
K133597	CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGL	Cook, Inc.	2014-04-18	147	1
K131772	CANTATA(R) 2.9 MICROCATHETER	Cook, Inc.	2014-02-20	248	0
K131204	ADVANCE CS CORONARY SINUS INFUSION CATHETER	Cook, Inc.	2014-01-29	275	0
K133634	SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CAT	Cook, Inc.	2013-12-23	27	0
K132020	ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER	Cook, Inc.	2013-10-25	116	0
K131201	ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SE	Cook, Inc.	2013-10-07	161	0
K131206	COOK CERVICAL RIPENING BALLOON	Cook, Inc.	2013-09-27	151	0
K132334	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PI	Cook, Inc.	2013-08-16	21	0
K122091	COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK	Cook, Inc.	2013-07-29	378	0
K130766	ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE	Cook, Inc.	2013-07-17	119	1
K122917	CODA BALLOON CATHETER	Cook, Inc.	2013-06-28	276	0
K130293	ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER	Cook, Inc.	2013-05-31	114	0
K130444	H-30 HOLMIUM LASER SYSTEM	Cook, Inc.	2013-05-22	90	0
K122940	ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHET	Cook, Inc.	2013-03-19	176	0
K123707	ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE	Cook, Inc.	2013-02-28	87	0
K122937	SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), S	Cook, Inc.	2012-12-14	81	4
K122796	CXI SUPPORT CATHETER	Cook, Inc.	2012-10-11	29	0
K113300	ATB ADVANCE PTA DILATATION CATHETER	Cook, Inc.	2011-12-09	30	0
K112185	FOURSNARE VASCULAR RETRIEVAL SNARE	Cook, Inc.	2011-11-02	96	1
K111244	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PI	Cook, Inc.	2011-06-14	42	0
K110009	ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE	Cook, Inc.	2011-02-02	30	1
K101450	CANTATA MICROCATHETER	Cook, Inc.	2010-12-30	220	0
K101728	FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE	Cook, Inc.	2010-08-25	65	0
K101877	OCCLUSION BALLOON CATHETER MODEL OBC	Cook, Inc.	2010-08-06	31	0
K100283	VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CA	Cook, Inc.	2010-04-23	81	0
K093209	FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE	Cook, Inc.	2010-02-26	136	0
K093469	CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRO	Cook, Inc.	2010-01-08	63	17
K093052	CROSSCATH SUPPORT CATHTER	Cook, Inc.	2009-12-08	69	0
K091385	APPROACH HYDRO ST WIRE GUIDE, MODEL HMW	Cook, Inc.	2009-08-07	89	1
K091527	ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER	Cook, Inc.	2009-06-12	17	0
K090822	ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER	Cook, Inc.	2009-04-27	32	0
K090624	COOK MREYE EMBOLIZATION COILS	Cook, Inc.	2009-04-02	24	0
K090133	CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS	Cook, Inc.	2009-02-20	30	0
K080737	MIRAFLEX HIGH FLOW MICROCATHETER	Cook, Inc.	2008-08-08	144	0
K080037	MODIFICATION TO ZILVER 635 BILIARY STENT	Cook, Inc.	2008-08-01	207	0
K081113	COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS	Cook, Inc.	2008-07-30	103	105
K081690	SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CAT	Cook, Inc.	2008-07-14	27	0
K073627	FLEXOR EVAC ASPIRATION CATHETER	Cook, Inc.	2008-03-04	69	0
K073378	ADVANCE 18LP PTA DILATATION CATHETER	Cook, Inc.	2007-12-28	25	0
K072625	TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PI	Cook, Inc.	2007-12-13	87	9
K072724	CXI SUPPORT CATHETER	Cook, Inc.	2007-11-09	44	1
K072240	GUNTHER TULIP VENA CAVA FILTER	Cook, Inc.	2007-11-08	87	0
K072148	CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY	Cook, Inc.	2007-10-03	61	0
K071640	VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODE	Cook, Inc.	2007-07-12	27	1
K070410	COOK MICROWIRE WIRE GUIDE	Cook, Inc.	2007-04-27	74	0
K063619	FLIPPER DETACHABLE EMBOLIZATION COILS	Cook, Inc.	2006-12-20	15	0
K063252	ATB ADVANCED PTA DILATATION CATHETER	Cook, Inc.	2006-11-14	18	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