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

IWJ — Predicate Candidate Screening

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

88 daysmedian FDA review time

354 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K010166	IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM	Imagyn Medical Technologies, Inc.	2001-12-03	319	0
K980997	PGK DEVICE (MODIFIED)	Pgk, Inc.	1998-09-28	195	0
K972554	REGANES RADIONUCLIDE SEED MAGAZINE	Avid N.I.T., Inc.	1998-02-17	224	0
K973037	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	Avid N.I.T., Inc.	1998-01-27	166	0
K974118	WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET	Worldwide Medical Technologies, LLC	1998-01-23	84	0
K973786	NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND	Nw Radiation Therapy Products	1998-01-02	88	0
K973638	N.I.T., INC. NEEDLE GUIDING TEMPLATE	Avid N.I.T., Inc.	1997-12-23	90	0
K973184	PROSTATE SEEDING NEEDLE	Promex, Inc.	1997-11-21	88	0
K963743	MANAN PROSTATE UNI-LOCK	Manan Medical Products, Inc.	1996-12-06	80	0
K951052	WEEKS APPLICATOR	Duke University Medical Center	1996-08-22	535	0
K961377	MANAN PROSTATE LOCKING INTRODUCER SET	Manan Medical Products, Inc.	1996-07-03	84	0
K944522	MORGANSTERN PROSTATE STABILIZATION AND SEEDING KIT	Medical Device Technologies, Inc.	1995-02-24	161	1
K933410	IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PE	Best Industries	1994-12-30	533	0
K940121	IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS	Best Industries	1994-12-30	354	0
K940550	COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH	Cook, Inc.	1994-08-17	191	0
K924290	BEST INDUSTRIES CARTRIDGE & GUN	Best Industries	1993-06-04	287	0
K913293	QUICK SEEDER	Mick Radio-Nuclear Instruments, Inc.	1992-10-13	447	0
K921886	NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE	Needle Technologies, Inc.	1992-10-05	167	0
K921961	SDMO APPLICATOR CODE: ASN.8236	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1992-07-01	65	0
K910862	VARIOUS TEMPLATE APPLICATORS	Best Industries	1991-04-18	48	0
K904933	VARIOUS AFTERLOADING APPLICATORS	Best Assoc. Corp.	1991-01-04	64	0
K903403	CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR	University of Michigan	1990-10-01	62	0
K901842	PLASTIC-GUIDES	M & K Co.	1990-07-11	78	0
K893703	AFTER LOADING DEVICE KIT	Medical Radiation Devices, Inc.	1989-09-18	123	0
K890485	WANG FRONT LOADING APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1989-04-14	73	0
K891377	HILARIS-NORI CERVIX APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1989-04-14	36	0
K890341	MICK 200-TP AND MICK TP NEEDLE	Mick Radio-Nuclear Instruments, Inc.	1989-03-14	50	1
K890191	HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN	Amersham Corp.	1989-02-06	19	0
K871216	HILARIS-NORI ENDOMETRIAL APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1987-07-21	117	0
K871217	HENSCHKE AFTERLOADING APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1987-07-16	112	0
K871213	KUMAR CERVICAL APPLICATOR	Mick Radio-Nuclear Instruments, Inc.	1987-07-16	112	0
K850571	I-125 IMPLANT GUN	Mick Radio-Nuclear Instruments, Inc.	1985-03-26	41	0
K832738	HEYER-SCHULTE AFTERLOADING CATHETER	American Heyer Schulte	1983-09-29	48	0
K813230	AFTERLOADING GYNECOLOGICAL APPLICATOR	Esi	1981-12-29	49	0
K801983	SCOTT NEEDLE & SCOTT MICK IMPLANTER	Mick Radio-Nuclear Instruments, Inc.	1980-10-23	65	0
K800320	CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.	Amersham Corp.	1980-03-25	42	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