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 2074 of 3531

510(k) clearances, page 2074 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935788	Bicore Smartcath Intratracheal Catheter	Bicore Monitoring Systems	MOD	Class II	1995-07-03
K932922	Procide 14 N.s., Omnicide/liquid & Plus Liq Activator	Cottrell, Ltd.	MED	Class II	1995-07-03
K952461	Endo Prosthesis Femoral Head	Globus Medical, Inc.	JDI	Class II	1995-06-30
K952276	Mpm Hydrogel Dressing	MPM Medical	MGQ	Unclassified	1995-06-30
K952183	Diastat Anti-Thyroglobulin Kit	Shield Diagnostics, Ltd.	JZO	Class II	1995-06-30
K952165	Trans-Aire Rigid Gas Permeable Contact Lens	Rand Scientific Corp.	HQD	Class II	1995-06-30
K952088	Zirconia Articul/eze Femoral Balls	Depuy, Inc.	LZO	Class II	1995-06-30
K951886	Lok-on Needle Disposal System	Becton Dickinson Vacutainer Systems	GIM	Class II	1995-06-30
K951828	Full Dynamic Range Compression Behind the Ear Hearing Instrument	Siemens Hearing Instruments, Inc.	ESD	Class I	1995-06-30
K951587	Beltone Petite Plus Beltone Petite Plus Clearvioce K	Beltone Electronics Corp.	ESD	Class I	1995-06-30
K951553	3I Asyst Abutment Package System	ZimVie US Corp LLC	DZE	Class II	1995-06-30
K951536	Hydragel Protein(e) Kit	Sebia	CEF	Class I	1995-06-30
K951487	Diastat Anti-Thyroid Peroxidase Kit	Shield Diagnostics, Ltd.	JZO	Class II	1995-06-30
K951419	Flex D-4000	U.S. Table, Inc.	INQ	Class I	1995-06-30
K951386	Combination Camera/light Source	M.P. Video, Inc.	GCJ	Class II	1995-06-30
K951175	Medical Imaging Information and Capture System (Miics)	Sirius Corp.	LMD	Class I	1995-06-30
K950820	Spinal Specialties Pencil-Point Spinal Needle	Spinal Specialties, Inc.	BSP	Class II	1995-06-30
K950730	Group Auditory Trainer (Group Amplification System)	Phonic Ear, Inc.	EPF	Class II	1995-06-30
K950704	K4 Bone Screw System	Kinetikos Medical, Inc.	HWC	Class II	1995-06-30
K950533	Trophy Radiologie Rvg Radiovisiography	Trophy Radiologie	EAP	Class II	1995-06-30
K950413	Medipacs	Nexsys Electronics	LMD	Class I	1995-06-30
K950196	Culture Media, for Isolation of Pathogenic Neisseria	Bioclinical Systems, Inc.	JTY	Class II	1995-06-30
K946232	Acura-Ex	Lustgarten Multi-Tech Intl.	ESD	Class I	1995-06-30
K945884	Specific Ige Ultra-Eia	Hycor Biomedical	DHB	Class II	1995-06-30
K944219	Single Pass Blood Cardioplegia Spbc System Components	Gish Biomedical, Inc.	DTR	Class II	1995-06-30
K944029	Continuous Epidural Anesthesia Tray	Spinal Specialties, Inc.	CAZ	Class II	1995-06-30
K943713	Torcars,cannulae,sheaths,obturators	Karl Storz Endoskop GmbH	HET	Class II	1995-06-30
K943319	Gertie Marx Epi-Spinal Tray	Spinal Specialties, Inc.	CAZ	Class II	1995-06-30
K941973	Gip/medi-Globe Guide Wires & Wind-Up Guide Wires	Medi-Globe GmbH	FGE	Class II	1995-06-30
K941740	Acufex Rotator Cuff Fixation Button	Acufex Microsurgical, Inc.	KGS	Class I	1995-06-30
K941566	Compuspeak	Hogan & Hartson	LLZ	Class II	1995-06-30
K952598	Gx-Pan Panoramic Dental X-Ray System	Gendex Corp.	GEX	Class II	1995-06-29
K952524	Aesculap Biopolar Coagulator	Aesculap Inc	GEI	Class II	1995-06-29
K952200	Omni-Jug	Waterstone Medical, Inc.	KDG	Class I	1995-06-29
K952148	Axsym Ultrasensitive Htsh II	Abbott Medical	JLW	Class II	1995-06-29
K951964	Synchron Enzyme Validator Set	Beckman Instruments, Inc.	JIS	Class II	1995-06-29
K951878	Spacemaker, II Surgical Balloon Dissector with and without a Cannula	General Surgical Innovations	GCJ	Class II	1995-06-29
K951576	Fs-34P2, Fiber Sigmoidoscope	Pentax Precision Instrument Corp.	FAM	Class II	1995-06-29
K951486	Model Pv2000 Vascular Microlaboratory	Vasamedics, LLC	DPW	Class II	1995-06-29
K951155	Cedia Folate (No Boil) Assay	Microgenics Corporation	CGN	Class II	1995-06-29
K951087	Tendril, Unipolar Endocardial Screw-in Lead	Pacesetter, Inc.	DTB	Class III	1995-06-29
K950899	Laboratory Sharps Barrel	Biosystems S.A.	FMI	Class II	1995-06-29
K950588	T4 Microwell Eia (Enzyme Immunoassay0	Biomerica	KLI	Class II	1995-06-29
K950054	Endo-Bend(tm) Shaver	Paladin Medical, Inc.	HRX	Class II	1995-06-29
K944007	Europhilic Slippery Coated Foley Catheter	Baxter Healthcare Corporation	EZL	Class II	1995-06-29
K933934	Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit No. 202-a	Sigma Diagnostics, Inc.	JBF	Class II	1995-06-29
K952702	Derma Seal	Ttl Medical	FPX	Class I	1995-06-28
K952317	Kaplan-Simpson InfusaSleeve II Catheter	Localmed, Inc.	QEY	Class II	1995-06-28
K952097	Otosonic (Osi) Cf 10-K, 10-D	Beltone Electronics Corp.	ESD	Class I	1995-06-28
K952091	Vutler G.u.m. with Fluoride	John O. Butler Co.	JES	Class I	1995-06-28