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 1525 of 3531

510(k) clearances, page 1525 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K012609	Clearmedical/nellcor Oxisensor II, Neonatal/adult, Model N-25	Clearmedical, Inc.	NLF	Class II	2002-07-03
K012600	Clearmedical/nellcor Oxisensor II, Adult, Model D-25/D-25L	Clearmedical, Inc.	NLF	Class II	2002-07-03
K002741	Browne Tst Single Use Bowie Dick/integrator Test Pack	Sybron Dental Specialties, Inc.	JOJ	Class II	2002-07-03
K022020	Justwo Model Tme-601 Root Apex Locator	Toei Electric Co., Ltd.	LQY	Unclassified	2002-07-02
K021984	Punctsure Ultrasound Vascular Imaging System; Puncturesure Vascular Imaging Procedure Kit	Inceptio Medical Technologies, LC	IYN	Class II	2002-07-02
K021966	Q Lab Software	Advanced Technology Laboratories, Inc.	LLZ	Class II	2002-07-02
K021961	Powder-Free Poly-Vinyl Exam Gloves, Color: White	Copioumed Intl., Inc.	LYZ	Class I	2002-07-02
K021941	Samplok Luer Kit	Itl Corporation Pty, Ltd.	JKA	Class II	2002-07-02
K021911	Trident Crossfire Polyuethylene Liners	Howmedica Osteonics Corp	LPH	Class II	2002-07-02
K021830	Sorin Biomedica Smarxt Bcd Vanguard Surface Modified Cardioplegia System	LivaNova USA, Inc.	DTR	Class II	2002-07-02
K021829	Modification to Kodak Directview Cr 800/900 System	Eastman Kodak Company	MQB	Class II	2002-07-02
K021824	Dynalink .035 Biliary Self-Expanding Stent System, Models 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010	Boston Scientific Corporation	FGE	Class II	2002-07-02
K021566	Infiniti	Alcon Laboratories	HQC	Class II	2002-07-02
K021534	Iq Nasal Mask, Model 50160 Rev. D	SleepNet Corporation	BZD	Class II	2002-07-02
K021521	Sterile Powder Free Latex Examination Gloves with Protein Claim Less Than 50U/g of Gloves	Smart Glove Corp. Sdn Bhd	LYY	Class I	2002-07-02
K021419	Aart Malar Implant	Aesthetic and Reconstructive Technologies, Inc.	LZK	Class II	2002-07-02
K021418	Aart Nasal Implant	Aesthetic and Reconstructive Technologies, Inc.	FZE	Class II	2002-07-02
K021417	Aart Chin Implant	Aesthetic and Reconstructive Technologies, Inc.	FWP	Class II	2002-07-02
K021346	Stem Hip Replacement System, Model Pha002xx	Wrightmedicaltechnologyinc	LPH	Class II	2002-07-02
K021318	Xive Dental Implant System	Friadent GmbH	DZE	Class II	2002-07-02
K021314	Sceptre-Vs	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2002-07-02
K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corporation	GEX	Class II	2002-07-02
K021146	D/sense 1-Step	Centrix, Inc.	EJK	Class II	2002-07-02
K021124	Accufix Tilting Radiotranslucent Headholder	Anholt Technologies Inc.	IYE	Class II	2002-07-02
K020399	Resperate; Model Rr-150	Intercure, Ltd.	HCC	Class II	2002-07-02
K020386	Invacare Platinum, Models Irc 5Lx and Irc 5Lx02	Invacare GmbH	CAW	Class II	2002-07-02
K020021	Lyra Surgical Laser System and Accessiories (Nd:yag Configuration)	Laserscope	GEX	Class II	2002-07-02
K014255	Dinamap Procare Series Monitor; Model 100, 200, 300, 400	GE Medical Systems Information Technologies, Inc.	MWI	Class II	2002-07-02
K014208	Ssir System	Russian-American Technology Associates, Inc.	ILY	Class II	2002-07-02
K013689	Re-Entrant Chamber	Sun Nuclear Corporation	KPT	Class II	2002-07-02
K013205	Millar Pressure Control Unit Model Pcu-2000	Millar LLC.	DRQ	Class II	2002-07-02
K010065	Cranial Stereotactic Equipment	Arplay Medical S.A.	IYE	Class II	2002-07-02
K021895	Bio-Logic Master Evoked Response System	Bio-Logic Systems Corp.	GWJ	Class II	2002-07-01
K021883	Biofastin Rc Threaded Suture Anchor	Mitek Worldwide	HWC	Class II	2002-07-01
K021869	Owl Radiofrequency System, Model Urf-2Ap	Diros Technology, Inc.	GXD	Class II	2002-07-01
K021831	Opaque Herrick Lacrimal Plug, 0.3Mm,0.5mm,0.7mm, Models Hlp3-Opb,hlp50opb,hlp7-Opb	Lacrimedics, Inc.	LZU	Unclassified	2002-07-01
K021828	Small Hammer Toe Pin	Zimmer GmbH	HWC	Class II	2002-07-01
K021825	Modification to Spiral Radius 90-D Sst System	Unitedstates Surgical	KWP	Class II	2002-07-01
K021349	Metal Transcend Articulation System (Larger Sizes)	Wrightmedicaltechnologyinc	KWA	Class III	2002-07-01
K021317	Triage B-Type Natriuretic Peptide (Bnp) Test	Biosite Incorporated	NBC	Class II	2002-07-01
K021221	O&p Cranical Molding Helmet	Orthotic & Prosthetic Lab, Inc.	MVA	Class II	2002-07-01
K021196	Neuron Therapeutics, Inc., 14-Gauge Lumbar Puncture Set, Model Pn1000735	Neuron Therapeutics, Inc.	JXG	Class II	2002-07-01
K021165	New Heights Electric Elevating Power Wheelchair Model No. 08 02 Series	Bromac Assistive Technology	IPL	Class II	2002-07-01
K021164	Macropore Os Trauma	Macropore Biosurgery, Inc.	HRS	Class II	2002-07-01
K021079	Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336Xx	Conmedcorp	GEI	Class II	2002-07-01
K021071	Pccs Graft Delivery System	Zimmer GmbH	FMF	Class II	2002-07-01
K021063	Great Toe Implant	Whiteside Biomechanics, Inc.	KWD	Class II	2002-07-01
K020714	Rusch Floneil; Flocath Introgel	Rusch Intl.	GBM	Class II	2002-07-01
K020486	Careside Ggt	Careside, Inc.	JPZ	Class I	2002-07-01
K013182	Triple Lumen Central Venous Catheter	Cook Inc.	FOZ	Class II	2002-07-01