510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2496 of 3531

510(k) clearances, page 2496 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903358	Advance Laparotomy Sponge, Lap Sponge	Advance Medical Designs Inc	GDY	Class I	1990-11-29
K902647	Curity Pediatric Continuous Caudal Anesthesia Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1990-11-29
K902157	Johnson & Johnson Dual Syringe Applicator	Johnson & Johnson MEDICAL GmbH	FMF	Class II	1990-11-29
K901536	Sterile View Disp. Hood/gown UV, Barrier Hood, UV	Depuy, Inc.	FYA	Class II	1990-11-29
K900696	Biore Cp-100 Cardiopulmonary Monitor	Bicore Monitoring Systems	BZC	Class II	1990-11-29
K900001	Corometrics Model 556 Neonatal Monitor	GE Medical Systems Information Technologies, Inc.	DQA	Class II	1990-11-29
K905096	Ggt Reagents, 7738, 7739, 7538, 7438 & 7138	Amresco, Inc.	JQB	Class I	1990-11-28
K905057	Ez-Screen:barbiturates	Environmental Diagnostics, Inc.	DIS	Class II	1990-11-28
K904995	Abuscreen Online Tm for Cocaine Metabolite	Roche Diagnostic Systems, Inc.	KLN	Class II	1990-11-28
K904898	Torque Frame Qtf1000	Medmetric Corp.	IKK	Class II	1990-11-28
K904765	Emit (R) II Phencyclidine Assay	Syva Co.	LCM	Unclassified	1990-11-28
K904698	Secondary Calibrators	Bionostics, Inc.	JIT	Class II	1990-11-28
K904683	Stratus Primidone Fluorometric Enzyme	Baxter Healthcare Corporation	LFT	Class II	1990-11-28
K904184	Biotrol Hdl Cholesterol Precipitation Reagent	Biotron U.S.A., Inc.	LBR	Class I	1990-11-28
K904115	Hycor Accupinch Methamphetamine Test	Hycor Biomedical	DKZ	Class II	1990-11-28
K903490	Norplant(r) Trocar	Wyeth-Ayerst Laboratories, Inc.	FMI	Class II	1990-11-28
K905156	Bio Medx Air Flotation System	Bio Clinic Co.	IOQ	Class II	1990-11-27
K904915	Caress Massager	Kendex Corp.	ISA	Class I	1990-11-27
K904386	Urolab Janus	Life-Tech Intl., Inc.	FAP	Class II	1990-11-27
K904299	Slim Line Retent Tip W/silicone Inflation Cuff	E-Z-EM, Inc	FGD	Class II	1990-11-27
K904210	Renatron II Dialyzer Reprocessing System Rs 8330	Medivators Inc	LIF	Class II	1990-11-27
K904156	Origin(tm) Cement Extract Syst Std-Pr/spl-Pr Kits	Origin Medsystems, Inc.	LZV	Class II	1990-11-27
K904140	Single Lumen Catheters, Modification	Akcess Medical Products, Inc.	LFJ	Class II	1990-11-27
K903579	Flexiflo Stomate Decompression Tube	Abbott Medical	KNT	Class II	1990-11-27
K893924	Moto-Med RF-II and Pico	Holl Meditronics, Inc.	BXB	Class I	1990-11-27
K905113	Roto Rest; Trauma and Intensive Care Bed	Ethos Medical Products, Ltd.	IKZ	Class II	1990-11-26
K905053	Stage Zero Air Flotation Bed	Lake Medical Products, Inc.	IOQ	Class II	1990-11-26
K904958	Tempest Electric Wheelchair	Everest & Jennings, Inc.	ITI	Class II	1990-11-26
K904950	Manual and Motorized Flexion Distraction Tables	Leander Research, Mfg & Distr., Inc.	INQ	Class I	1990-11-26
K904949	A.o. Synthes,tap(replacement)various Model Numbers	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1990-11-26
K904796	Medical Alert System, Model 2200 & 4400 V/t	Personal Emergency Response System	ILQ	Class II	1990-11-26
K904522	Various Models of Wheelchairs	Hadco Marketing Services, Inc.	INI	Class II	1990-11-26
K904411	Intrasite Gel (Labeling Revision)	Smith & Nephew United, Inc.	KMF	Class I	1990-11-26
K904375	Kimono Plus	Mayer Laboratories	HIS	Class II	1990-11-26
K904350	Cui Dorsal Columella Prosthesis	Cui Corp.	FZE	Class II	1990-11-26
K904349	Cui Curvilinear Silicone Chin	Cui Corp.	FWP	Class II	1990-11-26
K904348	Cui Feathered Silicone Malar	Cui Corp.	LZK	Class II	1990-11-26
K903957	Vsp Hip Stem	Turnkey Intergration USA, Inc.	JDI	Class II	1990-11-26
K903617	Muscle Massager	Uri Halfon and Gabriel Hertzberg	ISA	Class I	1990-11-26
K903040	A-1103 Abutment (Removable)	Minimatic Implant Technology	DZE	Class II	1990-11-26
K902926	Color Velocity Imaging (Cvi) Option for Platinum	Philips North America LLC	ITX	Class II	1990-11-26
K902525	Ace/williams Microsurgery Saw System	Buckman Co., Inc.	HWE	Class I	1990-11-26
K894475	Mentor Tissue Expanders W/tdmac Coating	Mentor	LCJ	Unclassified	1990-11-26
K904526	Hypoallergenic Cranberry/malaytex Latex Exam Glove	Malaytex USA, Inc.	LYY	Class I	1990-11-23
K904453	Labelling Modification to Maxx Plus	Mayer Laboratories	HIS	Class II	1990-11-23
K904433	Dual Lumen Needles	Akcess Medical Products, Inc.	LBW	Class II	1990-11-23
K904111	Htr Polymer, Htr-Mx	United States Surgical, A Division of Tyco Healthc	KKY	Class II	1990-11-23
K903959	Neonatal Metascope	Cybermedic, Inc.	BZK	Class II	1990-11-23
K903806	Angiotec Image Management System	Andros Analyzers, Inc.	LMB	Class I	1990-11-23
K903416	Cannula, Surgical	Advantage Diagnostics Corp.	GEA	Class I	1990-11-23