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

JOS — Predicate Candidate Screening

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

84 daysmedian FDA review time

157 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161600	Resection Electrodes	Olympus Winter & Ibe GmbH	2016-09-06	89	0
K050923	LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGR	Conmed Linvatec	2005-05-18	35	1
K012684	REPROCESSED ELECTROSURGICAL ELECTRODE	Sterilmed, Inc.	2002-01-18	157	1
K011515	MEDLINE GROUNDING PAD	Medline Industries, Inc.	2001-07-13	57	0
K003403	ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999	Highland / Marietta, Inc.	2001-05-07	187	0
K000333	STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STAND	Triad Surgical Technologies, Inc.	2000-05-03	90	0
K993885	ULTRABLATOR ELECTRODE	Linvatec Corp.	2000-02-10	86	0
K991830	CAPSULAR SHRINKAGE ELECTRODE	Linvatec Corp.	1999-08-20	84	0
K974735	STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STAND	Aaron Medical Industries	1998-06-24	188	0
K973554	VALLEY FORGE BIPOLAR BALL TIP ELECTRODE	Valley Forge Scientific Corp.	1997-12-19	91	0
K971187	STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EX	Aaron Medical Industries	1997-05-05	34	0
K962544	MICRO DIAMOND-POINT DISSECTION NEEDLES	Dsp Worldwide	1996-09-20	84	0
K962313	MODIFIED LEVEEN NEEDLE ELECTRODE	Radiotherapeutics Corp.	1996-09-11	86	0
K955636	SENTRY DISPOSABLE DISPERSIVE ELECTRODE	Sentry Medical Products, Inc.	1996-03-27	107	0
K952290	MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICA	Mist, Inc.	1995-06-23	38	0
K952323	MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES	Mist, Inc.	1995-06-23	36	0
K950455	DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORI	Aaron Medical Industries	1995-05-16	102	0
K944992	ELECTRODES	Linvatec Corp.	1995-04-27	197	0
K923037	MILES SODIUM METHOD	Heraeus Kulzer, Inc.	1992-09-22	95	0
K905060	ELECTRODE EXTENDER	Megadyne Medical Products, Inc.	1991-04-12	155	0
K903302	ELECTRODE, ELECTROSURGERY	Megadyne Medical Products, Inc.	1990-10-02	70	0
K895331	ELECTROSURGICAL ELECTRODE	New England Surgical Instrument Corp.	1989-09-15	16	0
K891400	MICRO CAUTERY NEEDLES	Zinnanti Surgical Instruments, Inc.	1989-04-06	23	0
K890973	STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE	Instrument Makar, Inc.	1989-03-22	23	0
K890972	HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE	Instrument Makar, Inc.	1989-03-22	23	0
K882421	INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE	Dermacare Products, Inc.	1988-06-30	17	0
K881763	COLORADO NEEDLE ELECTRODE	Colorado Biomedical, Inc.	1988-06-20	56	0
K881144	YESNG PATIENT PLATE #80226	Ferguson Medical	1988-04-08	22	0
K874719	STRATUM ESU	Alternative Design Systems, Inc.	1988-02-16	91	0
K873653	MONOPOLAR CAUTERY BLADE TIP #TM-1701	Arthropedics, Inc.	1987-12-15	96	0
K873654	MONOPOLAR CAUTERY CONICAL TIP #TM-1702	Arthropedics, Inc.	1987-12-15	96	0
K873655	MONOPOLAR CAUTERY RETROGADE TIP #TM-1703	Arthropedics, Inc.	1987-12-15	96	0
K810628	ELECTROSURGICAL CUTTING & COAGULATION	Intermedics, Inc.	1981-04-03	25	0
K792365	BIPOLAR FORCEPS	Concept, Inc.	1979-12-10	17	0
K780405	INFANT ELECTROSURGICAL GROUNDING PAD	New Dimensions IN Medicine, Inc.	1978-04-05	23	0
K772160	ELECTROSURGICAL GROUNDING PAD	Ndm Corp.	1977-11-28	12	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