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

Anago, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time

170 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days
K925659	U.C.E.Z. LENS CLEANER KIT	Anago, Inc.	1993-09-17	345
K930161	ANAGO SPINAL ANESTHESIA TRAY	Anago, Inc.	1993-07-06	174
K926137	ANAGO FEM-COOL/FEM-COOL PETITE	Anago, Inc.	1993-05-26	170
K926590	ANAGO DISPOSABLE INSTANT COLD PACK	Anago, Inc.	1993-05-26	170
K926589	ANAGO WARM PACK	Anago, Inc.	1993-05-26	170
K920615	ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT	Anago, Inc.	1993-03-20	403
K915415	GUARDALL SHIELD	Anago, Inc.	1992-10-15	321
K913558	RELIABLE CONE STYLE FACE MASK	Anago, Inc.	1991-11-07	90
K905865	ANTI-FOR SURGICAL FACE MASK	Anago, Inc.	1991-03-06	72
K905749	SURGICAL FACE MASK	Anago, Inc.	1991-03-04	70
K904276	DISPOSABLE BEARD COVER	Anago, Inc.	1990-11-21	63
K904274	RECEIVING BLANKET	Anago, Inc.	1990-10-26	38
K902547	THE PROTECTOR II, LASER SURGICAL MASK	Anago, Inc.	1990-09-05	89
K902546	THE PROTECTOR & HIGH PERFORMANCE SPLASH MASK	Anago, Inc.	1990-09-05	89
K875008	GUARDALL SHIELD	Anago, Inc.	1988-03-11	98
K864670	BOARD, ARM (WITH COVER)	Anago, Inc.	1987-01-12	41
K864116	ANAGO ISOLATION MASK (#80-950)	Anago, Inc.	1986-11-25	35
K862126	STERILE LAPAROTOMY GAUZE SPONGE	Anago, Inc.	1986-06-19	15
K861928	STERILE O. R. TOWEL	Anago, Inc.	1986-06-09	20
K861318	DISPOSABLE NEEDLE COUNTER (20-720)	Anago, Inc.	1986-05-02	24
K861307	DISPOSABLE NEEDLE COUNTER	Anago, Inc.	1986-05-02	24
K861316	DISPOSABLE NEEDLE COUNTER (20-240)	Anago, Inc.	1986-05-02	24
K861317	DISPOSABLE NEEDLE COUNTER (20-530)	Anago, Inc.	1986-05-02	24
K861319	DISPOSABLE NEEDLE COUNTER (20-560)	Anago, Inc.	1986-05-02	24
K843721	DISPOSABLE ISOLATION GOWN	Anago, Inc.	1984-10-25	31
K843038	DISPOSABLE PATIENT BLANKET	Anago, Inc.	1984-10-24	83
K843037	DISPOSABLE LAPAROTOMY SPONGE	Anago, Inc.	1984-09-05	34
K842438	DISPOSABLE SURGERY HOOD	Anago, Inc.	1984-08-02	42
K842453	DISPOSABLE PREPING PAD	Anago, Inc.	1984-08-02	41
K820893	DISPOSABLE SURGICAL FACE MASK	Anago, Inc.	1982-04-14	15
K813097	ANAGO STERILE PRODUCTS; STOCKINETTES	Anago, Inc.	1982-03-10	127
K812105	ANOGO DISPOSABLE SHOE COVER	Anago, Inc.	1981-09-11	49
K810199	DISPOSABLE SURGERY CAPS & HOODS	Anago, Inc.	1981-02-13	21
K810264	DISPOSABLE PILLOW	Anago, Inc.	1981-02-09	7
K802980	DISPOSABLE STERILE LAP SPONGE	Anago, Inc.	1980-12-19	25
K802186	DISPOSABLE NURSES CAP	Anago, Inc.	1980-09-26	16
K800197	ANAGO DISP., ALL PURPOSE PATIENT REST.	Anago, Inc.	1980-02-26	27
K800058	ANAGO ELECTRO SURGICAL TIP CLEANER	Anago, Inc.	1980-01-28	18
K791412	DISPOSABLE INSTRUMENT TRAY PAD	Anago, Inc.	1979-08-16	20
K790634	IMPERVIOUS STERILE STOCKINETTE	Anago, Inc.	1979-04-10	7
K790039	COUNTER, DISPOSABLE SURGICAL NEEDLE	Anago, Inc.	1979-01-17	9
K782092	ARMBOARD CVER, DISPOSABLE	Anago, Inc.	1979-01-10	27
K782091	STOCKINETTE, DISPOSABLESURGICAL	Anago, Inc.	1979-01-10	27
K782144	DISPOSABLE SURGICAL INSTRUMENT TIP	Anago, Inc.	1979-01-05	9

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