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 1021 of 3531

510(k) clearances, page 1021 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092062	Everon 1.0	Earlysense, Ltd.	BZQ	Class II	2010-05-24
K101139	Prostiva RF Therapy Model 8929 Hand Piece	Medtronic, Inc.	KNS	Class II	2010-05-21
K101113	Guardian II Nc Hemostasis Valve	Zerusa Limited	DTL	Class II	2010-05-21
K100849	Sync-Rx System, Model As00010	Sync-Rx, Ltd.	IZI	Class II	2010-05-21
K100847	Synthetic Seeding Spacer Model Ss9 X 50-50, Ss9 X 55-50, Ss9 X 55-150, Ss9 X 1Cm-30	Biocompatibles, Ltd.	KXK	Class II	2010-05-21
K100769	Penumbra System Separator Flex (026,032,041,054), Models Psf026, Psf032, Psf041, Psf054	Penumbra Inc.	NRY	Class II	2010-05-21
K100750	Audit Microcv Aso Linearity Set, Model K721m-5	Aalto Scientific Ltd.	JJX	Class I	2010-05-21
K100686	Conmed Macrolyte Dispersive Electrode	ConMed Corporation	GEI	Class II	2010-05-21
K100626	Doppler Fetal Heart Rate Detector, Model Fm-200	Shenzhen Biocare Electronics Co., Ltd.	KNG	Class II	2010-05-21
K100363	Ultra Dci Model 5000	Ultrasound Medical Devices, Inc.	IYO	Class II	2010-05-21
K100349	Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2010-05-21
K100232	Luminesse Zr Blanks	Talladium Inc	EIH	Class II	2010-05-21
K100154	Fixcet Spinal Facet Screw System	Xtant Medical Holdings, Inc.	MRW	Unclassified	2010-05-21
K093168	Mediflash and Esteflash	Dermeo	ONF	Class II	2010-05-21
K092695	Transcorp Trans-Plate Anterior Cervical Plate System	Transcorp	KWQ	Class II	2010-05-21
K092528	Biomet Forerunner Locking Plate System	Biomet Trauma (Aka Ebi, LP)	HRS	Class II	2010-05-21
K092454	Vitek 2 Yeast Voriconazole	bioMerieux, Inc.	NGZ	Class II	2010-05-21
K091734	Sonic Shot Gx	Nemoto Kyorindo Co., Ltd.	IZQ	Class II	2010-05-21
K091556	Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls	Instrumentation Laboratory Co.	MSV	Class II	2010-05-21
K090861	Mambo, Model Cs 18Xx-Xx	Ulrich GmbH & Co. KG	KWQ	Class II	2010-05-21
K101175	Kfx Appianfx Peek Femoral Implant with Inserter	Kfx Medical	MBI	Class II	2010-05-20
K101169	Desara Mesh Model: Cal-Ds01	Caldera Medical, Inc.	OTN	Class II	2010-05-20
K100699	Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Star Plastic Co., Ltd.	LYZ	Class I	2010-05-20
K100677	Lympha Press 201Max, Model 201Max	MEGO AFEK AC Ltd.	JOW	Class II	2010-05-20
K100616	Knockout Sr Medium, Knockout Sr Xenofree Medium Model 10828, 12618	Life Technologies Corporation	NDS	Class II	2010-05-20
K100369	Powder-Free Nitrile Gloves, Black	HL Rubber Industries Sdn Bhd	LZA	Class I	2010-05-20
K100365	Farrell Valve with Corflo Anti-IV Connectors Model 20-4300Aiv	Halyard Health	KNT	Class II	2010-05-20
K100194	Optical Integrity Laserguard Fibers	Optical Integrity, Inc.	GEX	Class II	2010-05-20
K093895	Ally Platform System	Continuity Health Solutions	DRG	Class II	2010-05-20
K092689	Manukapli Wound Dressing	Manuka Medical Limited	FRO	Unclassified	2010-05-20
K092628	Enteral Feeding Tube and Accessories, Feeding Tube Extension Set	Alan Reid	KNT	Class II	2010-05-20
K092617	Royal Guard	Shun Thai Rubber Gloves Industry Public Co., Ltd.	LZA	Class I	2010-05-20
K101151	Regent Anterior Cervical Plate	Custom Spine, Inc.	KWQ	Class II	2010-05-19
K100856	Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)	Suzhou Shengyuda Plastic Products Co., Ltd.	LYZ	Class I	2010-05-19
K100462	Jetstream G3 L System, Pv Console, Models Pv31400, Pv31300, Pvcn100	Pathway Medical Technologies, Inc.	MCW	Class II	2010-05-19
K093992	Terumo Lauer Lock Adapter	Terumo Cardiovascular Systems Corporation	DTL	Class II	2010-05-19
K093939	Advia Chemistry Salicylate Reagent	Siemens Healthcare Diagnostics Inc.	DKJ	Class II	2010-05-19
K093820	Subfix Arthroereisis Implant, Models Sut0065, Sut0080, Sut0090, Sut0100, Sut0115	Memometal Technologies	HWC	Class II	2010-05-19
K093479	Disposable Suction and Irrigation System	Modern Medical Equipment Mfg., Ltd.	FHF	Class II	2010-05-19
K083798	Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf	Medicrea Technologies	MAX	Class II	2010-05-19
K101184	Titan Ti Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006	ArthroCare Corporation	MBI	Class II	2010-05-18
K100735	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Rayu Plastic Products Limited	LYZ	Class I	2010-05-18
K100734	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Huanfu Plastic Products Limited	LYZ	Class I	2010-05-18
K100193	Otomag Bone Conduction Hearing System	Sophono, Inc.	LXB	Class II	2010-05-18
K100008	Cardo Medical Ceramic Hip System	Cardo Medical Corp.	LZO	Class II	2010-05-18
K094061	Kensey Nash Ecm Surgical Patch	DSM Biomedical, Inc.	FTM	Class II	2010-05-18
K093218	Femeye Two	Fem Suite, LLC	HIH	Class II	2010-05-18
K092229	Thyretain Tm Tsi Reporter Bioassay	Ortho-Clinical Diagnostics, Inc.	JZO	Class II	2010-05-18
K092129	Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model 2026,2026-Ch, 2310, 2320, 2330	Intersurgical Ltd.	BZE	Class II	2010-05-18
K101094	Clearjet	Easyglide, Ltd.	ODC	Class II	2010-05-17