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

KYZ — Predicate Candidate Screening

41 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

230 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201877	OtoSet- Ear Cleaning System	Safkan, Inc.	2020-11-05	121	0
K102563	SINGLE CANNULA EXTENDED APPLICATOR	Micromedics, Inc.	2011-03-15	189	0
K092022	TISSU TRANS HARVEST TUBING	Shippert Medical Technologies Corp.	2009-08-17	42	0
K050797	TISSU-TRANS	Shippert Medical Technologies Corp.	2005-07-13	106	0
K991254	QS DELIVERY SYSTEM	Sub-Q, Inc.	1999-08-23	132	0
K982435	IRRIGATION SYRINGE KIT	Sub-Q, Inc.	1998-11-06	116	0
K974288	ZEROWET SPLASHIELD	Zerowet, Inc.	1998-01-29	76	0
K964833	RMI DUAL FLUID IRRIGATING SYRINGE	Research Medical, Inc.	1997-02-19	79	0
K960725	MARPP PRESSURE MONITORING SYSTEM	Paradigm Medical, Inc.	1996-07-15	144	0
K960212	CPR IRRIGATION TRAY	Custom Pack Reliability	1996-04-01	76	0
K952406	REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W	Contour Fabricators of Florida, Inc.	1995-08-07	77	0
K952407	REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE	Contour Fabricators of Florida, Inc.	1995-08-07	77	0
K933171	INMAN IRRIGATION TAPERED PROBE	Inman Medical Corp.	1994-04-29	304	0
K940371	SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP	Micromedics, Inc.	1994-04-06	90	0
K930610	TALC DISPENSER SYRINGE	Nusurg, Inc.	1993-11-04	272	0
K924517	AVITENE DISPENSER SYRINGE	Nusurg, Inc.	1993-10-27	418	0
K931912	IRRIGATING BLUNT DISSECTOR	Mayaguez Medical Center	1993-08-10	116	0
K931946	WELCH ALLYN EARCLEANER	Welch Allyn, Inc.	1993-07-26	98	0
K924809	IRRIGATION TRAY W/ BULB SYRINGE	Customed, Inc.	1993-06-07	256	3
K905173	SPLASH GUARD	E.M. Adams	1991-04-25	160	0
K905365	INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM	Instrument Makar, Inc.	1991-02-06	77	0
K903759	IRRICLEAR EAR IRRIGATION SYRINGE	Nortech Laboratories, Inc.	1990-10-26	67	0
K900208	ZEROWET SPLASHIELD	Zerowet Splashield	1990-09-04	230	0
K902854	GRAVITY ASSIST	Instrument Makar, Inc.	1990-08-29	61	0
K896800	IRRIGATION TRAY	Westmark, Sterile Packing Systems, Inc. (Sps)	1990-05-24	174	0
K894470	STRYKER TRAUMA TRAY	Stryker Corp.	1989-08-18	31	0
K890728	STERILE IRRIGATION TRAYS	Cypress Medical Products, Ltd.	1989-06-16	123	0
K884786	EAR IRRIGATION SET 101 (EARIGATOR)	Physicians Supply Co.	1989-04-26	162	0
K884749	JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE	Johnson & Johnson Patient Care, Inc.	1988-12-15	31	0
K883506	IRRIGATION KIT	L H M Ent., Inc.	1988-12-13	118	0
K883338	SURGICAL SEALANT APPLICATOR	Micromedics, Inc.	1988-08-23	14	2
K881020	SURGICAL SEALANT DISPENSER (SSD)	Micromedics, Inc.	1988-03-25	15	1
K830572	CLEAN-FLUSH	Burron Medical Products, Inc.	1983-03-17	22	0
K821530	SYRINGE IRRIGATING	Medcare Disp Products, Inc.	1982-05-28	7	0
K813027	STERILE IRRIGATING SYRINGES, KITS,TRAY	Welcon, Inc.	1981-11-20	23	0
K810251	SYRINGE, ENT	Megaplast, Inc.	1981-03-11	41	0
K810209	IRRIJET	Ackrad Laboratories	1981-02-17	22	0
K803200	IRRIGATION SET W/BULB SYRINGE	Walpak Co.	1981-01-21	35	0
K801573	SAPCRILL THERMODETECT BREAST SCANNER DEV	California Cardiac Systems, Inc.	1980-09-09	62	0
K791998	60CC IRRIGATING SYRINGE, PISTON TYPE,	Waz Industries, Inc.	1979-10-26	21	0
K780794	IRRIGATION CAP	Travenol Laboratories, S.A.	1978-07-27	73	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