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

The Kendal Co. — Predicate Candidate Screening

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

57 daysmedian FDA review time

119 days90th percentile

63clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K000087	MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR	The Kendal Co.	2000-03-17	65	0
K990500	KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL	The Kendal Co.	1999-09-28	223	1
K991758	MONOJECT INSULIN SYRINGE	The Kendal Co.	1999-06-14	21	0
K970969	KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT	The Kendal Co.	1997-04-23	37	0
K951488	KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP	The Kendal Co.	1995-04-25	25	0
K942664	KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM	The Kendal Co.	1995-01-17	225	0
K942774	POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING	The Kendal Co.	1994-07-20	37	0
K892434	KENDALL CURITY OXYGEN MASK	The Kendal Co.	1989-08-15	127	0
K892440	KENDALL CURITY EXTENSION TUBES	The Kendal Co.	1989-07-24	105	0
K892438	KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES	The Kendal Co.	1989-07-24	105	0
K892436	KENDALL CURITY IRRIGATION SYRINGE	The Kendal Co.	1989-07-14	95	0
K892442	KENDALL CURITY URETHRAL CATHETERS	The Kendal Co.	1989-06-23	74	0
K892437	KENDALL KENGUARD URINARY LEG BAGS	The Kendal Co.	1989-06-23	74	0
K892439	KENDALL CURITY STOMACH TUBES	The Kendal Co.	1989-06-23	74	0
K892432	KENDALL CURITY ENDOTRACHEAL TUBES	The Kendal Co.	1989-06-12	63	0
K892435	KENDALL CURITY OXYGEN NASAL CANNULA	The Kendal Co.	1989-06-12	63	0
K892441	KENDALL CURITY SUCTION CATHETERS	The Kendal Co.	1989-05-31	51	0
K892431	KENDALL CURITY FEEDING TUBES	The Kendal Co.	1989-05-19	39	0
K892433	KENDALL CURITY URINARY DRAINAGE BAGS	The Kendal Co.	1989-05-05	25	0
K885238	CURITY CONTINUOUS SPINAL ANESTHESIA TRAY	The Kendal Co.	1989-02-22	63	0
K881667	KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH	The Kendal Co.	1988-08-12	116	0
K873111	CONFORMA(TM) PLASTER BANDAGES	The Kendal Co.	1987-10-09	60	0
K872310	CURAD MEDICATED PLASTIC STRIPS	The Kendal Co.	1987-08-28	74	0
K871066	CURITY CONTINUOUS EPIDURAL ANESTHESIA TRAY	The Kendal Co.	1987-05-15	59	0
K871296	T.E.D.(TM) TRACTION DEVICE	The Kendal Co.	1987-04-15	15	0
K864103	CURITY ANESTHESIA FILTER	The Kendal Co.	1987-01-28	99	0
K863581	MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB	The Kendal Co.	1986-10-31	46	0
K861827	CURITY CENTRAL VENOUS CATHETERIZATION TRAY	The Kendal Co.	1986-07-11	60	0
K861829	CURITY CENTRAL VENOUS CATHETER	The Kendal Co.	1986-07-10	59	0
K861828	CURITY VENOUS CATHETERIZATION KIT	The Kendal Co.	1986-07-10	59	0
K855061	CURITY PERCUTANEOUS CATHETER INSERTION KIT	The Kendal Co.	1986-04-16	119	0
K855060	CURITY PERCUTANEOUS CATHETER INSERTION TRAY	The Kendal Co.	1986-04-16	119	0
K855137	CURITY FIBEROPTIC INTUBATING AIRWAY	The Kendal Co.	1986-03-11	78	0
K860484	CURITY & KENGUARD SILICONE COATED FOLEY CATHETER	The Kendal Co.	1986-03-11	29	1
K854862	CURITY URETERAL STENT	The Kendal Co.	1986-02-10	67	0
K852083	THE KENDALL URINARY OUTPUT MONITOR	The Kendal Co.	1985-09-20	130	0
K852084	KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP	The Kendal Co.	1985-09-20	130	0
K853145	KENDALL CURITY BURN PAD	The Kendal Co.	1985-08-30	32	0
K852085	KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG	The Kendal Co.	1985-08-07	86	0
K842840	CURITY SILICONE NEPHROSTOMY CATHETER	The Kendal Co.	1984-10-04	76	0
K842899	CURITY SUPRAPUBIC DRAINAGE SYSTEM	The Kendal Co.	1984-09-10	49	0
K842898	CURITY I.V. START KIT	The Kendal Co.	1984-08-17	25	1
K841169	CURITY RIG FOLEY CATH TRAY	The Kendal Co.	1984-07-06	109	0
K840850	ANESTHESIA VENTILATOR CIRCUIT	The Kendal Co.	1984-03-19	24	0
K840849	SCAVENGER TUBING 19MM	The Kendal Co.	1984-03-12	17	0
K833790	CURITY 100% SILICONE COUDE' CATHETER	The Kendal Co.	1983-12-27	57	17
K832692	CURITY CATHETER STRAP	The Kendal Co.	1983-09-12	33	0
K832609	A.V.R. KNEE LENGTH THERAPEUTIC STOCK-	The Kendal Co.	1983-09-12	40	0
K831121	CURITY LEG BAG	The Kendal Co.	1983-04-28	23	0
K822424	CURITY TRANSPARENT FILM DRESSING	The Kendal Co.	1982-12-17	127	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