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 1987 of 3531

510(k) clearances, page 1987 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K960907	Orca	Lunar Corp.	OXO	Class II	1996-05-20
K960708	Benzodiazepine Serum Tox Eia Test	Diagnostic Reagents, Inc.	JXM	Class II	1996-05-20
K955703	Neo Dental Endodontic Irrigation Syringe	Neodental Chemical Products Co., Ltd.	KIF	Class II	1996-05-20
K955673	Cell Dyn 3000 Multi-Parameter Automated Hematology Analyzer (Modification)	Abbott Medical	GKZ	Class II	1996-05-20
K955646	Vicryl Peridontal Mesh	Ethicon, Inc	NPK	Class II	1996-05-20
K954953	B-D Durasafe Combined Spinal Epidural (Cse) Tray	BD Becton Dickinson Vacutainer Systems Preanalytic	CAZ	Class II	1996-05-20
K954548	The Chen Medium	Chen Ophthalmic Laboratories	LYX	Unclassified	1996-05-20
K951449	Model Km-25	Koven Technology, Inc.	IYO	Class II	1996-05-20
K961756	Cytoquant Viral Transport Medium	Proteins Intl., Inc.	JSN	Class I	1996-05-17
K961755	Cytoquant Chlamydia Transport Medium	Proteins Intl., Inc.	JSN	Class I	1996-05-17
K961622	Phonak Piconet2 P2 Az	Phonak, Inc.	ESD	Class I	1996-05-17
K961201	Bosworth Impression Material II	Harry J. Bosworth Co.	ELW	Class II	1996-05-17
K961200	Bosworth Liquid Resin II	Harry J. Bosworth Co.	EBI	Class II	1996-05-17
K961157	Whiteside Biomechanics Cancellous Bone Screw	Whiteside Biomechanics, Inc.	HWC	Class II	1996-05-17
K960887	Mouse Anti-Human Cd4, T-Cell, Helper/inducer/fitc & Cd8, T-Cell, Suppressor/cytotoxic/rpe	Dako Corp.	GKZ	Class II	1996-05-17
K960827	Qbc Accutube(423406)/qbc Autoread(424571)	Becton Dickinson Diagnostic Instrument Systems	GKZ	Class II	1996-05-17
K960807	Tew Cranial/spinal Retractor Model A1090	Ohio Medical Instrument Co., Inc.	GZT	Class II	1996-05-17
K960776	Micro21 with Retic	Triangle Biomedical Sciences, Inc.	JOY	Class II	1996-05-17
K960675	Walkhaler Portable Compressor Model 45F70	Pari Holding Co.	CAF	Class II	1996-05-17
K960663	Universal Bite Block	B & B Medical Technologies, Inc.	JXL	Class II	1996-05-17
K960642	Nancy Nail	Landos, Inc.	HTY	Class II	1996-05-17
K960641	Recap-1	Medscience Research Group, Inc.	FMI	Class II	1996-05-17
K955800	Si2000 (Sense-It Trademark) or G2000; Disposable Resting Electrode	Cmc Sense-It, Inc.	DRX	Class II	1996-05-17
K955291	Dualscreen	Medtronic, Inc.	GZB	Class II	1996-05-17
K955286	Ektachem Clinical Chemistry Slide Glucose (Glu)	Johnson & Johnson Clinical Diagnostics, Inc.	CGA	Class II	1996-05-17
K955146	Axiom-Hvg	Axiom Manufacturing	IPF	Class II	1996-05-17
K951951	Focus Model 795 Unit	Empi	GZJ	Class II	1996-05-17
K944497	Unilect, Monitab and Biotrace-Hr	Msb, Ltd.	DRX	Class II	1996-05-17
K941593	Diagnostic Ultrasonic Transducer	Toshiba America Medical Systems, In.C	IYO	Class II	1996-05-17
K961746	Chronoswiss,baleno,bonia,otmar Alt, New Jersey	Eurotrends Eyewear, Inc.	HQY	Class I	1996-05-16
K961524	Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators	Sterilab, Inc.	HNY	Class I	1996-05-16
K961286	Stussy Sunglasses/a.j. Morgan Sunglasses	Intl. Optical Mfg. Co., Ltd.	HQY	Class I	1996-05-16
K961224	Hydro-Flex Li Laparoscopic Irrigation System	Davol Inc., Sub. C.R. Bard, Inc.	GCJ	Class II	1996-05-16
K961168	Viewpoint	Philips North America LLC	GAW	Class II	1996-05-16
K961087	Deroyal Surgical (Surgimate) Pencil Adapters	Debusk Knitting Mills, Div. Deroyal Industries	GEI	Class II	1996-05-16
K961067	Burn-Aid Hydrogel,burn Dressing,burn Blanket	Medtrak Intl., Inc.	MGQ	Unclassified	1996-05-16
K961057	Duralastic Sheeting II	Rand Scientific Corp.	MIB	Class II	1996-05-16
K960954	Ketac-Molar Aplicap	Espe GmbH & Co. KG.	EMA	Class II	1996-05-16
K960821	Slt Fumich Probe Guide	Surgical Laser Technologies, Inc.	GEX	Class II	1996-05-16
K955777	Pmma Clasic	Rand Scientific Corp.	HPX	Unclassified	1996-05-16
K955304	Cricket	Microvena Corp.	DQX	Class II	1996-05-16
K954419	Spectacle Frames/sunglasses	Ami Fashion	HQY	Class I	1996-05-16
K954389	Conmed Ecg/ekg Electrodes	Conmedcorp	DRX	Class II	1996-05-16
K954053	Berlin External Fixator	Encore Orthopedics, Inc.	LXT	Class II	1996-05-16
K953559	Larkel Device with Attachments a-H(modification)	Seidel Medizin GmbH	BTO	Class II	1996-05-16
K953434	Midas Rex Motors, (Midas I, Midas II & Convertible Models)	Midas Rex Pneumatic Tools, Inc.	HBB	Class II	1996-05-16
K950335	Karl Storz Rigid Telescopes for Obsterics and Gynecology	Karl Storz Endoscopy-America, Inc.	HET	Class II	1996-05-16
K944496	Biotrace-N, Ns, 410 and Rt	Msb, Ltd.	DRX	Class II	1996-05-16
K941553	Magnes II Biomagnetometer	Biomagnetic Technologies, Inc.	OLX	Class II	1996-05-16
K961492	Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010	Davol Inc., Sub. C.R. Bard, Inc.	GCJ	Class II	1996-05-15