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 1898 of 3531

510(k) clearances, page 1898 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971403	Smart - Glove Powder Free Latex Examination Glove	Sj Medical Products (M) Sdn Bhd	LYY	Class I	1997-05-29
K971396	Ck Reagent	Carolina Liquid Chemistries	CGS	Class II	1997-05-29
K971372	Variolink II	Ivoclar North America, Inc.	EBF	Class II	1997-05-29
K971345	Chol or Cholesterol	Carolina Liquid Chemistries	CHH	Class I	1997-05-29
K971216	Frigiderm Frigispray	Dermatologic Lab & Supply, Inc.	GEH	Class II	1997-05-29
K971113	Dma Triglycerides Procedures	Data Medical Associates, Inc.	CDT	Class I	1997-05-29
K970980	Cardiac Scoring for CT Scanners	Elscint, Inc.	JAK	Class II	1997-05-29
K970803	Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe	Retractable Technologies, Inc.	MEG	Class II	1997-05-29
K964861	Acupuncture Needles	C.A.M. Supply, Inc.	MQX	Class II	1997-05-29
K964791	B2 Microglobulin Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)	Bayer Corp.	JZG	Class II	1997-05-29
K964767	Quantikine IVD Beta-2-Microglobulin Enzyme Immunoassay (Eia(	R & D Systems, Inc.	JZG	Class II	1997-05-29
K964438	511 Kev Collimator	Trionix Research Laboratory, Inc.	KPS	Class II	1997-05-29
K963990	Gyroscan T5-Nt, Gyroscan T10-Nt and Gyroscan Acs-Nt Release 5 Series	Philips North America LLC	LNH	Class II	1997-05-29
K963068	Cts-200 with Ezu-Pl21 Transducer	Shantou Institute of Ultrasonic Instuments	IYO	Class II	1997-05-29
K963065	Cts-285 with Ezu-Pl21 and Ezu-Pc3b Transducers	Shantou Institute of Ultrasonic Instuments	IYO	Class II	1997-05-29
K962142	Sonoline Versa 555 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYO	Class II	1997-05-29
K961229	Hr12000 Ultrasound System	International Ultrasound Corp.	IYO	Class II	1997-05-29
K971544	Synthes (USA) Compact Air Drive II (Cad II)	Synthes (USA) Products LLC	HWE	Class I	1997-05-28
K971480	Duralastic I and Duralastic II	Allied Biomedical Corp.	MIB	Class II	1997-05-28
K971156	Kasha Visual Field System	Kasha Software, Inc.	HPT	Class I	1997-05-28
K971034	Usci Mainstay Guiding Catheter	C.R. Bard Inc	DQO	Class II	1997-05-28
K970842	Cordis Endeavor Infusion Catheter	Cordis US Corp.	QEY	Class II	1997-05-28
K970828	Uhs Micronet Programmable Hearing Aids Models 901,902,903,906,909/Programmer	United Hearing Systems, Inc.	ESD	Class I	1997-05-28
K970797	Olympus Psd-20 Electrosurgical System and Accessories	OLYMPUS Corporation of the Americas	GEI	Class II	1997-05-28
K970685	Earcheck Pro	Mdi Instruments, Inc.	ETY	Class II	1997-05-28
K970526	Arthrocare Monopolar Electrosurgery Loop	ArthroCare Corporation	FAS	Class II	1997-05-28
K964881	Ultraverse Pta Catheter	Vas-Cath, Inc.	LIT	Class II	1997-05-28
K964607	Theraton 1000E	Theratronics, Inc.	IWD	Class II	1997-05-28
K964223	Clinitron Rite-Hite	Hill-Rom Inc.	INX	Class II	1997-05-28
K961104	Notebook Imager	Digirad Corp.	IYX	Class I	1997-05-28
K952545	Wright 1000 Monoplace Hyperbaric System	Wright Industries	CBF	Class II	1997-05-28
K971777	Quantex Aso-Crp-RF Control	Instrumentation Laboratory Co.	JJT	Class I	1997-05-27
K971485	Uric Acid - Incorporating Dynamic Stabilization Technology - (Dst)	Trace America, Inc.	CDO	Class I	1997-05-27
K971477	Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (Dst)	Trace America, Inc.	CDQ	Class II	1997-05-27
K971312	Immulite Pyrilinks-D	Siemens Healthcare Diagnostics Inc.	JMM	Class I	1997-05-27
K971237	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl8108	Alexander Mfg. Co.	MRZ	Class II	1997-05-27
K971234	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl825	Alexander Mfg. Co.	MRZ	Class II	1997-05-27
K971213	Alexander Manufacturing Co. Rechargeable Battery # Gl825-P	Alexander Mfg. Co.	MRZ	Class II	1997-05-27
K971212	Alexander Manufacturing Co. Rechargeable Battery Part Number Gl4018	Alexander Mfg. Co.	MRZ	Class II	1997-05-27
K971204	Lsvp International Hot Biopsy Forceps	Lsvp Intl., Inc.	KGE	Class II	1997-05-27
K971202	Comeg Optical Stone Crushing Forceps, Comeg Visual Obturators for Urology, Comeg Optical Biopsy Forceps	Comeg Endoskopie GmbH	OCZ	Class II	1997-05-27
K970814	Non-Sterile Isolation Gown	American Seal Co.	FYC	Class II	1997-05-27
K970786	Alexander Mfg. Rechargeable Battery (Model M7)	Alexander Mfg. Co.	MRZ	Class II	1997-05-27
K970776	Lifecore O-Ring Abutment;lifecore Dalla Bona Abutment	Lifecore Biomedical LLC	DZE	Class II	1997-05-27
K970718	Quantikine IVD Stfr Enzyme Linked Immunosorbent Assay (Elisa)	R & D Systems, Inc.	JNM	Class II	1997-05-27
K970554	Convertors Sms Drapes	Medtronic, Inc.	KKX	Class II	1997-05-27
K964802	Cyberjet Local Anesthesia System	Intra Vantage, Inc.	EGM	Class II	1997-05-27
K964252	Orthochuck	Buckman Co., Inc.	GEY	Class I	1997-05-27
K963423	Ksea CO2 Endoflator	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1997-05-27
K971658	Mouse Liver Kidney Stomach Diagnostic Test Kit	Jay H. Geller	DBL	Class II	1997-05-23