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

JOL — Predicate Candidate Screening

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

87 daysmedian FDA review time

308 days90th percentile

84clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K051370	STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CAR	Baxter Healthcare Corp	2005-08-12	78	0
K000266	PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE F	Primary Care Solutions, Inc.	2001-07-12	531	0
K000265	PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION	Primary Care Solutions, Inc.	2001-07-12	531	0
K003402	WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0	Welcon, Inc.	2001-05-01	181	0
K994321	STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP	Automatic Liquid Packaging, Inc.	2000-10-25	308	0
K974759	HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML	Hydrox Laboratories	1998-03-09	80	0
K974758	HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER	Hydrox Laboratories	1998-03-09	80	0
K974397	STERILE SALINE FOR CATHETER CARE	Baxter Healthcare Corp	1998-02-10	81	0
K973734	STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVI	Welcon, Inc.	1998-02-05	128	0
K972372	GERM TRAPPER SUCTION TUBE HOLDER	Rzv Medical Specialties, Inc.	1997-12-11	169	0
K960216	CPR SUCTION CATHETER KIT	Custom Pack Reliability	1996-04-15	90	0
K954442	STERILE ISOTONIC SALINE & STERILE WATER	Medcare Custom Packaging, Inc.	1995-12-21	87	0
K950201	ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER	Sherwood Medical Co.	1995-12-15	331	0
K951524	THORACENTESIS CATHETER	Baxter Healthcare Corp	1995-07-06	94	0
K945728	CATCO THORACIC CATHETER	Catco Medical, Inc.	1995-05-23	182	0
K943661	STERILE PHYSIOLOGICAL SALINE/STERILE WATER	Medcare Custom Packaging, Inc.	1995-04-10	256	0
K943773	STERILE WATER	Medline Industries, Inc.	1995-02-27	209	0
K943832	STERILE .9% SODIUM CHLORIDE FOR IRRATION	Orion Life Systems, Inc.	1994-11-21	108	0
K943831	PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER	Orion Life Systems, Inc.	1994-11-21	108	0
K943836	PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER	Orion Life Systems, Inc.	1994-11-21	108	0
K943828	STERILE WATER FOR IRRIGATION	Orion Life Systems, Inc.	1994-11-21	108	0
K943829	PRE-FILLED SYSRINGE W/STERILE WATER	Orion Life Systems, Inc.	1994-11-21	108	0
K943830	PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION	Orion Life Systems, Inc.	1994-11-21	108	0
K943834	STERILE .9% SODIUM CHLORIDE SOLUTION	Orion Life Systems, Inc.	1994-11-21	108	0
K932138	SALINE FOR IRRIGATION	Rantran, Inc.	1994-11-04	562	0
K943833	STERILE WATER FOR IRRATION	Orion Life Systems, Inc.	1994-11-01	88	0
K931509	GERITREX STERILE SALINE SOLUTION FOR IRRIGATION	Geritrex Corp.	1994-09-22	545	0
K933762	STB YANKAUER SUCKER/NOZZLE	Save-T-Breath Distributors C.C.	1994-07-19	350	0
K942061	DISPOSABLE SUCTION PROBE	United States Surgical, A Division of Tyco Healthc	1994-05-16	17	0
K941232	THORA-CATH	Gesco Intl., Inc.	1994-05-11	57	0
K933526	STERILE WATER	Trinity Laboratories, Inc.	1994-03-10	232	0
K931511	GERITREX STERILE WATER FOR IRRIGATION	Geritrex Corp.	1994-02-14	325	0
K934382	VCI SUCTION/IRRIGATION TUBING SET	Vital Concepts, Inc.	1994-02-01	145	10
K932185	SURGICAL SUCTION TIP	Tlc Medservices, Inc.	1993-10-27	175	0
K922714	UNIVERSAL IRRIGATION & SUCTION TUBING SET	Ximed Medical Systems	1993-08-03	424	0
K913896	JAIN BLOOD SHIELD	Jain Surgical Equipment, Inc.	1992-03-06	189	0
K913876	ENDOTRACHEAL SUCTIONTUBE	Willowtech	1992-03-06	190	0
K910693	PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET	Baxter Healthcare Corp	1991-10-17	240	0
K910963	THOROCENTESIS KIT	Megadyne Medical Products, Inc.	1991-06-20	106	0
K904216	STERILE WATER SOLUTION CATALOG # 10000	Superior Healthcare Group, Inc.	1990-11-16	65	0
K903569	CURITY THORACENTESIS TRAY	Kendall Healthcare Products Co. Div.Of Tyco Health	1990-09-07	31	0
K890039	KLEEN TEST BASIN SET	Kleen Test Products	1989-10-24	287	0
K893667	SUCTION TIP	Thomson & Shelton Instrumentation Co, Inc.	1989-08-21	98	0
K893527	LAPAROSCOPIC SUCTION PROBE	Dexide, Inc.	1989-07-14	67	0
K893135	GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER	Premium Plastics, Inc.	1989-06-22	58	0
K883905	ARROW PNEUMOTHORAX KIT, AK-01500	Arrow Intl., Inc.	1989-01-19	126	0
K872948	URESIL THORA-FLO THORACENTESIS PROCEDURE KIT	Uresil Corp.	1987-11-27	122	0
K873563	APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY	Aplicare, Inc.	1987-11-23	82	0
K873464	VAN DELLEN CANNULA	Van Dellen, Ltd.	1987-11-23	87	0
K873525	DEKNATEL TROCAR CATHETER	Deknatel, Inc.	1987-11-02	62	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