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

Orion Life Systems, Inc. — Predicate Candidate Screening

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

108 daysmedian FDA review time

316 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K943835	PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID	Orion Life Systems, Inc.	1995-01-24	172	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
K943833	STERILE WATER FOR IRRATION	Orion Life Systems, Inc.	1994-11-01	88	0
K923168	DUAL PORT ENTERAL Y-ADAPTOR	Orion Life Systems, Inc.	1994-06-17	718	0
K923497	FLUSHING IRRIGATION SET	Orion Life Systems, Inc.	1994-03-21	614	0
K923156	TRACHEOSTOMY CARE TRAY	Orion Life Systems, Inc.	1993-08-18	415	0
K923496	URINARY CARE SUPPLIES	Orion Life Systems, Inc.	1993-05-27	316	0
K904801	ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE	Orion Life Systems, Inc.	1991-01-16	84	0
K903117	ORION STERILE OR TOWELS	Orion Life Systems, Inc.	1990-12-31	168	0
K902813	SHAVE PREP TRAY	Orion Life Systems, Inc.	1990-11-19	145	0
K902810	STERILE I.V. START KIT	Orion Life Systems, Inc.	1990-11-13	139	0
K902811	ROUTINE DRESSING TRAY	Orion Life Systems, Inc.	1990-09-25	90	0
K902814	SUCTION CATHETER, STERILE	Orion Life Systems, Inc.	1990-08-17	50	0
K902828	SUTURE REMOVAL TRAY	Orion Life Systems, Inc.	1990-08-08	41	0
K902830	PERI-BOTTLE	Orion Life Systems, Inc.	1990-08-06	39	0
K901185	FOLEY CATHETER INSERTION TRAY (10CC)	Orion Life Systems, Inc.	1990-07-20	129	1
K901181	CATHETER CARE TRAY	Orion Life Systems, Inc.	1990-07-20	129	0
K901183	URETHRAL CATHETER TRAY (PVC)	Orion Life Systems, Inc.	1990-07-20	129	0
K901184	URETHRAL CATHETER TRAY (LATEX)	Orion Life Systems, Inc.	1990-07-20	129	0
K901180	FOLEY CATHETER INSERTION TRAY (30CC)	Orion Life Systems, Inc.	1990-07-20	129	0
K901179	ENEMA BUCKET SET	Orion Life Systems, Inc.	1990-06-28	107	0
K901182	ENEMA BAG SET	Orion Life Systems, Inc.	1990-06-28	107	0
K901219	EXTERNAL LEG BAG	Orion Life Systems, Inc.	1990-06-27	106	0
K901109	WOUND TREATMENT KIT	Orion Life Systems, Inc.	1990-06-06	89	0
K896887	TRACHAEL SUCTION SET	Orion Life Systems, Inc.	1990-04-23	136	0
K900737	PISTON IRRIGATION TRAY	Orion Life Systems, Inc.	1990-04-19	62	0
K900736	BULB IRRIGATION TRAY	Orion Life Systems, Inc.	1990-04-17	60	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