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

Intermed, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

136 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K900857	NON STERILE PARENTERAL SUPPLY KIT	Intermed, Inc.	1990-05-22	88
K842166	INTERMED, INS STERILE WATER/SALINE	Intermed, Inc.	1985-02-12	257
K833126	DRESSING CHANGE TRAYS	Intermed, Inc.	1984-01-27	136
K833573	CENTRAL VEIN CATH. TRAY CC-20-1420	Intermed, Inc.	1984-01-11	91
K833574	PERCUTANEOUS SHEATH INTRODUCER TRAYS	Intermed, Inc.	1984-01-11	91
K833139	ACUTE HEMODIALYSIS TRAYS	Intermed, Inc.	1983-12-22	99
K833059	SUCTION CATHETER TRAYS	Intermed, Inc.	1983-12-12	95
K821269	TRACHEOSTOMY CARE TRAYS	Intermed, Inc.	1982-05-27	24
K791427	CATHETERIZATION TRAYS FOLEY AND URETHRAL	Intermed, Inc.	1979-09-07	43
K791426	PERITONEAL PAC	Intermed, Inc.	1979-08-28	33
K781748	IRRIGATION TRAY	Intermed, Inc.	1978-12-12	56
K781457	FOLEY CATHETERS	Intermed, Inc.	1978-09-20	29
K780837	URINARY DRAINAGE BAG	Intermed, Inc.	1978-07-27	65
K761360	8 LATEX EXTENSION TUBE WITH CONNECTOR	Intermed, Inc.	1977-01-10	11
K761059	MALE URINARY CATHETER, EXTERNAL	Intermed, Inc.	1976-12-02	14
K760260	BAG, DISPOSABLE URINARY LEG	Intermed, Inc.	1976-10-20	92

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