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 2026-11-05, 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 1792 of 3531

510(k) clearances, page 1792 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982550	Browser (Event Software) Model # 4500E	Respironics, Inc.	BZQ	Class II	1998-10-05
K982490	Tenor Spinal System	Sofamor Danek USA,Inc.	KWP	Class II	1998-10-05
K982489	Rfg-3C Plus	Radionics, Inc.	GXD	Class II	1998-10-05
K982099	Momentum No. Fs008 Wheelchair	Sriram Enterprises D.B.A. Momentum Group	IOR	Class I	1998-10-05
K982064	Action Storm Ranger II, Action Storm Power 9000	Invacare GmbH	ITI	Class II	1998-10-05
K981445	Ultima Airflow Sensor, 0510	Braebon Medical Corp.	BZQ	Class II	1998-10-05
K971549	Vmt System	Target Health, Inc.	LXV	Unclassified	1998-10-05
K983027	Trimethoprim/sulphamethoxazole	Ab Biodisk	JWY	Class II	1998-10-02
K982914	Aesculap Spine System Evolution: Additional Components	Aesculap Inc	MNI	Class II	1998-10-02
K982907	Magnatek 40	Magna Advanced Technologies, Inc.	DQA	Class II	1998-10-02
K982670	Contemporary Acetabular Component	Howmedica Corp.	JDI	Class II	1998-10-02
K982598	Oti Femoral Lock Total Hip System	Osteoimplant Technology, Inc.	JDI	Class II	1998-10-02
K982538	Belmont Portable Balloon Pump, Bard Transact Iabp	Belmont Medical Technologies	DSP	Class II	1998-10-02
K982375	Stryker Hip Arthoroscopy Set	Stryker Corp.	HRX	Class II	1998-10-02
K982359	Nc-Stat	Neurometrix, Inc.	JXE	Class II	1998-10-02
K982358	Histofreezer Device	OraSure Technologies, Inc.	GEH	Class II	1998-10-02
K980484	Aesculap Spine System Evolution	Aesculap Inc	MNI	Class II	1998-10-02
K983023	Modification to Cordis Brite Tip Catheter Sheath Introducer System	Cordis US Corp.	DYB	Class II	1998-10-01
K982848	Cobas Integra Ldl Direct Reagent Cassette Roche Calibrator Ldl Direct	Roche Diagnostic Systems, Inc.	MRR	Class I	1998-10-01
K981861	Liner 1:Hard Reline Liquid	Harry J. Bosworth Co.	EBI	Class II	1998-10-01
K981630	Vygon Double Lumen Umbilical Catheter	Schiff & Co.	FOS	Class II	1998-10-01
K981345	Cholestron Pro II Cholesterol Test	Lifestream Diagnostics, Inc.	CHH	Class I	1998-10-01
K981295	Upro	Abbott Medical	JGQ	Class II	1998-10-01
K980812	Imx Homocysteine	Axis Biochemicals, ASA	DFC	Class II	1998-10-01
K983161	Kurer Crown Saver K4 Anchor System-the Universal Kit, Kurer Standard K4 Anchor System- the Ready Core Kit, Kurer Fin-Loc	Sabre-K, Ltd.	ELR	Class I	1998-09-30
K983043	Seare Biomedical Silicone Block	Seare Biomedical Corp.	MIC	Class II	1998-09-30
K983041	Seare Biomedical Silicone Sheeting	Seare Biomedical Corp.	MIB	Class II	1998-09-30
K982891	California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands	California Medical Laboratories, Inc.	DTS	Class II	1998-09-30
K982868	Etest Rifampicin with Indications for S. Pneumoniae	Ab Biodisk	JWY	Class II	1998-09-30
K982822	Fenwal 20 Micron Pediatric Transfusion Filter Model 4C7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4C72	Baxter Healthcare Corporation	CAK	Class II	1998-09-30
K982807	Polymer Coated, Powder-Free Latex Examination Glove	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	1998-09-30
K982806	Chlorinated, Polymer Coated, Powder-Free Latex Examination Glove	Perusahaan Getah Asas Sdn. Bhd.	LYY	Class I	1998-09-30
K982781	Demolizer #47 One-Gallon Point of Generation Sharps Container	Thermal Waste Technology, Inc.	MMK	Class II	1998-09-30
K982779	Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer Cement Type 1	Medental Intl.	EMA	Class II	1998-09-30
K982763	Seare Biomedical Malar Implants	Seare Biomedical Corp.	LZK	Class II	1998-09-30
K982762	Seare Biomedical Pectoralis Implant	Seare Biomedical Corp.	MIC	Class II	1998-09-30
K982753	Seare Biomedical Nasal Implants	Seare Biomedical Corp.	FZE	Class II	1998-09-30
K982752	Seare Biomedical Chin Implants	Seare Biomedical Corp.	FWP	Class II	1998-09-30
K982704	Disposable Vinyl Synthetic Exam Gloves, Powder Free	Shanghai Antares Industries, Inc.	LYZ	Class I	1998-09-30
K982648	Joan II	Celanese Acetate Co.	EFQ	Unclassified	1998-09-30
K982623	Aesculap Needlescopic Instrument System	Aesculap Inc	GCJ	Class II	1998-09-30
K982620	Medivision Cystoscope	Medivision Scope Service Center, Inc.	FAJ	Class II	1998-09-30
K982509	Ortho Implant and Accessories	Straumann USA, LLC	OAT	Class II	1998-09-30
K982482	Handmaster Nms1	N.E.S.S. Nuromuscular Electrical Stimulation Syst	IPF	Class II	1998-09-30
K982463	Extracranial Radiotherapy System	Howmedica Corp.	IYE	Class II	1998-09-30
K982459	Tempfil F - 2	Sybron Dental Specialties, Inc.	EBG	Class II	1998-09-30
K982440	Nitrile Patient Examination Glove	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	1998-09-30
K982422	Eaglesoft Chairside	Eaglesoft, A Patterson Co.	LLZ	Class II	1998-09-30
K982349	Somatom Plus 4With Volume Zoom CT Scanners	Siemens Medical Solutions USA, Inc.	JAK	Class II	1998-09-30
K982256	Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump	Mckinley, Inc.	MEB	Class II	1998-09-30