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

GXD — Predicate Candidate Screening

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

141 daysmedian FDA review time

486 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251247	GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofre	Boston Scientific Neuromodulation Corporation	2025-08-07	106	0
K242057	COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, C	Avanos Medical, Inc.	2024-08-14	30	0
K232632	Racz Neurostat RF Generator	Epimed International	2024-05-24	268	0
K231675	OneRF Ablation System	Neuroone Medical Technologies Corp.	2023-12-06	181	0
K220122	APEX 6	Rf Innovations, Inc.	2023-03-15	421	0
K203293	Abbott Medical Grounding Pad, model RF-DGP-IS	ABBOTT MEDICAL	2022-01-21	438	0
K201610	IonicRF Generator	ABBOTT MEDICAL	2020-10-21	128	0
K192491	Coolief Radiofrequency Generator (CRG) System	Avanos Medical, Inc.	2020-02-21	163	1
K181864	Polaris RF Ablation System	Baylis Medical Company, Inc.	2019-01-02	174	0
K171143	Relievant Medsystems RF Generator	Relievant Medsystems	2017-08-18	122	0
K170242	MultiGen™ 2 RF Generator System	Stryker Corporation	2017-05-25	119	0
K101592	ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRI	Cheng Medical, Corporation	2011-10-06	486	0
K111576	NT 2000 LESIONING GENERATOR	Neuro Therm, Inc.	2011-09-20	106	2
K093185	OWL UNIVERSAL RF SYSTEM URF-3AP (ML)	Diros Technology, Inc.	2010-01-22	105	0
K082051	COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4	Cosman Medical, Inc.	2008-10-16	90	0
K081729	MODIFICATION TO GFX NERVE ABLATION SYSTEM	Bioform Medical, Inc.	2008-08-07	50	0
K071482	STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000	Synergetics, Inc.	2007-12-20	204	1
K063753	GFX NERVE ABLATION SYSTEM	Aci, Inc.	2007-06-20	183	0
K070336	STOCKERT NEURO N50, MODEL12267	Stockert GmbH	2007-06-14	129	0
K063489	STRYKER INTRADISCAL RF GENERATOR	Synergetics, Inc.	2007-05-23	187	0
K062758	OWL URF-3AP	Diros Technology, Inc.	2006-09-27	12	0
K052878	NT-1000	Neuro Therm, Inc.	2006-01-23	103	0
K040565	PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE	Physician Industries, Inc.	2004-07-22	141	0
K032601	STRYKER INTERVENTIONAL PAIN RF GENERATOR	Valley Forge Scientific Corp.	2004-04-01	220	1
K021869	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP	Diros Technology, Inc.	2002-07-01	25	0
K020354	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOME	Baylis Medical Co., Inc.	2002-05-03	88	0
K010202	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIO	Leslie W. Organ	2001-10-31	282	0
K002565	BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTI	Baylis Medical Co., Inc.	2001-05-03	259	0
K010969	NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES	Stryker Instruments	2001-04-20	18	0
K983214	RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES	Rita Medical Systems	2000-03-27	560	0
K982489	RFG-3C PLUS	Radionics, Inc.	1998-10-05	80	0
K965182	RFG-3CF	Radionics, Inc.	1997-03-12	78	0
K963577	RADIONICS SLUIJTER-MEHTA CANNULA	Radionics, Inc.	1996-11-21	76	0
K941823	LEKSELL NEURO GENERATOR AND ACCESSORIES	Elekta Instruments, Inc.	1996-03-22	709	0
K922064	MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE	Cardiotronics, Inc.	1992-12-01	211	0
K901540	MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR	Radionics, Inc.	1991-04-08	371	0
K896450	NEURO N 50 LESION GENERATOR	Leibinger & Fischer , Ltd.	1991-03-19	495	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