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

GAA — Predicate Candidate Screening

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

44 daysmedian FDA review time

90 days90th percentile

107clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K223625	CapnoSpot™ Pneumothorax Decompression Indicator	Pneumeric, Inc.	2023-03-28	113	0
K102274	ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT	Arvik Enterprises/ Mini Lap Technologies	2011-06-15	308	0
K011586	IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE	Diametrics Medical, Inc.	2001-11-16	177	0
K994151	PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES	Ximed/Prosure/Injectx	2000-03-01	83	0
K983200	INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX	Ximed/Prosure/Injectx	1998-12-11	88	0
K974741	MANAN ACCURA NEEDLE	Medical Device Technologies, Inc.	1998-01-08	20	1
K962425	BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1	Radi Medical Systems AB	1996-09-11	79	0
K961959	MD TECH BIOPSY SET FOR BONE AND BONE MARROW	Medical Device Technologies, Inc.	1996-07-19	60	0
K945109	MONOJECT BONE MARROW BIOPSY TRAYS	Sherwood Medical Co.	1994-11-14	27	0
K940025	MANAN BONE MARROW HARVEST NEEDLES	Manan Medical Products, Inc.	1994-02-25	53	0
K940024	MANAN GENERAL PURPOSE INTRODUCER NEEDLE	Manan Medical Products, Inc.	1994-02-25	53	0
K930158	BONE MARROW BIOPSY PROCEDURE TRAY	Symbiosis Corp.	1993-07-02	170	0
K925621	IRRIGATION/ASPIRATION TUBING SET	Kirwan Surgical Products, Inc.	1993-05-07	182	0
K924501	GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE	Symbiosis Corp.	1993-04-20	228	0
K925416	SYMBIOSIS BONE MARROW BIOPSY NEEDLE	Symbiosis Corp.	1993-02-23	119	0
K922614	TURKEL THORACENTESIS SYSTEM	Symbiosis Corp.	1992-07-30	58	0
K915417	KOPAN'S TARGET	Medical Device Technologies, Inc.	1992-01-14	43	0
K914608	BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120	Dlp, Inc.	1992-01-09	84	0
K913992	ASPIRATION/INJECTION NEEDLE	Northgate Technologies, Inc.	1991-10-30	55	0
K912074	BONE MARROW BIOPSY TRAY	Manan Medical Products, Inc.	1991-08-28	110	0
K910036	SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES	Surgical Technologies, Inc.	1991-04-04	90	0
K910117	REDDICK IRRIGATION/ASPIRATION SYSTEM	Ideal Medical, Inc.	1991-03-19	67	0
K901438	SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE	Telemed Systems, Inc.	1990-05-24	59	0
K897050	WILSON-COOK LUNG BIOPSY NEEDLE	Wilson-Cook Medical, Inc.	1990-04-16	119	0
K896606	JACKSON FINE NEEDLE ASPIRATION SYSTEM	National-Standard Medical Products	1990-01-04	44	0
K896605	KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)	National-Standard Medical Products	1990-01-04	44	0
K896019	MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.	Dlp, Inc.	1990-01-03	79	0
K895012	E-Z-EM VACUUM ASPIRATION SYRINGE	E-Z-Em, Inc.	1989-12-27	141	0
K894873	16 GA X 10 BULLET POINT NEEDLE	R. J. Doyle, Inc.	1989-09-22	52	0
K894875	20GA X 7-1/2 THREADING BULLET POINT NEEDLE	R. J. Doyle, Inc.	1989-09-22	52	0
K894874	14 INCH BULLET POINT NEEDLE	R. J. Doyle, Inc.	1989-09-22	52	0
K894872	16 GA X 6 BULLET POINT NEEDLE	R. J. Doyle, Inc.	1989-09-22	52	0
K894326	THORACENTISIS KIT	Mill-Rose Laboratory	1989-07-24	10	0
K883014	MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED	Sherwood Medical Co.	1988-07-28	9	0
K882105	CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM	Dianon Systems, Inc.	1988-07-11	53	0
K880377	NOVO VIVO MODEL #17140 AND #17135	Genesis Industries, Inc.	1988-04-04	68	0
K874000	PRIA-KIT (TM) PRIAPISM KIT S.S.	Canton Medical, Inc.	1987-12-30	90	0
K873124	ANCHOR BIOPSY NEEDLE	Anchor Products Co.	1987-09-08	29	0
K870893	MEDSURG CHIBA PTC NEEDLE	Medsurg Industries, Inc.	1987-03-25	20	0
K870896	NOTCH-NEEDLE, WESCOTT STYLE	Ocean Medical Products, Ltd.	1987-03-18	13	0
K864800	NAMIC CHIBA ASPIRATION BIOPSY NEEDLE	North American Instrument Corp.	1987-02-06	59	0
K864139	RANFAC CUT BIOPSY NEEDLE	Ranfac, Corp.	1986-11-05	14	0
K863848	MANAN BREST TUMOR LOCALIZATION NEEDLE	Manan Manufacturing Co., Inc.	1986-10-14	14	0
K863326	BONE MARROW TRAY	Packaging Technologies, Inc.	1986-09-16	20	0
K860582	TBI NEEDLE	Hobbs Medical, Inc.	1986-03-04	14	2
K855141	ANGIOMED FINE NEEDLES AND NEEDLE SET	Angiomed U.S., Inc.	1986-01-24	29	0
K854579	HYPODERMIC NEEDLE AND STYLET	Berkley and Co.	1985-12-17	32	0
K854238	NEEDLE W/STYLET FOR IMPLANTATION	Microvasive	1985-11-13	23	0
K853980	EROSA DISPOSABLE HYPODERMIC NEEDLE	Rose KG	1985-10-18	21	0
K852897	LEE BONE MARROW BIOPSY/ASPIRATION TRAY	Southland Instruments, Inc.	1985-08-21	43	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