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

General Medical Co. · Predicate Candidate Screening

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

59 daysmedian FDA review time

113 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K926269	PROCEDURE KIT	General Medical Co.	1993-08-27	252
K912975	OPERAND LUBRICATING JELLY	General Medical Co.	1991-09-27	81
K912132	OPERAND LUBRICATING JELLY	General Medical Co.	1991-08-07	85
K903669	GENESIS INSUFFLATING CATHETER	General Medical Co.	1990-09-12	30
K900110	OPERAND* LUBRICATING JELLY	General Medical Co.	1990-05-02	113
K853635	SUBDERM TM	General Medical Co.	1985-12-20	112
K844652	C.A.S.E. CONTAINER	General Medical Co.	1984-12-12	13
K831320	DRIONIC	General Medical Co.	1983-07-19	88
K820689	C.S.R. WRAPPERS	General Medical Co.	1982-04-09	28
K820521	STERILIZATION WRAP	General Medical Co.	1982-03-18	20
K802231	AIR VIVA II	General Medical Co.	1980-10-10	25
K772089	LAPAROTOMY SPOGNE	General Medical Co.	1977-11-11	7
K770583	MEDI-PAK LEMON GLYCEOIN SWABS	General Medical Co.	1977-05-26	59
K770488	ISOLATION GOWN	General Medical Co.	1977-05-23	70
K770476	EXAM GOWN	General Medical Co.	1977-05-06	56

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