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 2158 of 3531

510(k) clearances, page 2158 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940487	Isocam II (Dual Head Gamma Camera)	Independent Scintilation Imaging Systems, Inc.	KPS	Class II	1994-09-30
K935633	No-Mes	Ethox Corp.	KNT	Class II	1994-09-30
K935199	Surgical Apparel	Associated Hospital Services, Inc.	KKY	Class II	1994-09-30
K933300	Geister Surgical Int'l Monopolar Endoscopic Surg.inst.	Lyle Howard Corp.	KNF	Class II	1994-09-30
K926568	Baxter CT Dialyzer	Baxter Healthcare Corporation	KDI	Class II	1994-09-30
K925522	Centrysystem 3 with Charts/bp Option	C.G.H. Medical, Inc.	KOC	Class II	1994-09-30
K925405	Zinetics Composite Sensor Probe W/internal Ref.	Synectics-Dantec	FFT	Class I	1994-09-30
K925274	Autocomp(tm) Software and Calibrite(tm) Beads	Becton Dickinson Immunocytometry Systems	GKZ	Class II	1994-09-30
K923993	Wallstent Biliary Endoprotheses	Schneider U.S. Stent Div.	FGE	Class II	1994-09-30
K923046	Biologic Dt-1000 Machine	Hemocleanse, Inc.	KNT	Class II	1994-09-30
K944617	Surgi-Link Disposable Push Button Esu Pencil	Unimed Surgical Products, Inc.	GEI	Class II	1994-09-29
K943975	Euro Tech Platinum Chiropractic Table	Progressive Electrical Therapeutics	INW	Class I	1994-09-29
K943974	Euro Tech Marquise Chiropractic Table	Progressive Electrical Therapeutics	INW	Class I	1994-09-29
K943973	Euro Tech Sterling Roller Table	Progressive Electrical Therapeutics	JFB	Class II	1994-09-29
K943807	Royal Shield Pink Colored Non-Sterile Latex Examination Glove	Shield Gloves Manufacturer (M) Sdn Bhd	LYY	Class I	1994-09-29
K943651	Techna-Cut Aspiration Needle	Argon Medical Devices, Inc	KNW	Class II	1994-09-29
K943479	Genemed Yag 1000 Medical Laser	Genemed, Inc.	GEX	Class II	1994-09-29
K943360	Ohio Care Plus Incubator	GE Healthcare	FMZ	Class II	1994-09-29
K943262	Futura Junior 300/310	Merivaara Instrumentarium Corp.	FPO	Class II	1994-09-29
K943181	Dispensing Pin with One-Way Valve	B. Braun of America, Inc.	LHI	Class II	1994-09-29
K943147	Statlock Cv	Venetec, Inc.	KMK	Class I	1994-09-29
K943127	Pharmassure Large Volume Transfer Filters	Gelman Sciences, Inc.	FPB	Class II	1994-09-29
K943092	Family Fitness Shiatsu Massager	Conair LLC.	ISA	Class I	1994-09-29
K943072	Beta C Counter	Capintec Instruments, Inc.	KPT	Class II	1994-09-29
K941865	Xpert Nct	Reichert Ophthalmic Instruments, Div. Leica, Inc.	HKX	Class II	1994-09-29
K941621	Lorenz Surgical Finned Dental Implant	Zimmer GmbH	DZE	Class II	1994-09-29
K941620	Lorenz Surgical Cylinder Dental Implant	Zimmer GmbH	DZE	Class II	1994-09-29
K941619	Lorenz Surgical Threaded Dental Implant	Zimmer GmbH	DZE	Class II	1994-09-29
K940997	Al-3300	Hoya Corp. USA	HLM	Class I	1994-09-29
K940190	Ultima Unipolar Modular Head	Johnson & Johnson Orthopaedics, Inc.	KWL	Class II	1994-09-29
K940172	Cardiovascular Measurement System-Cms	Medis Medical Imaging Systems, B.V.	IZI	Class II	1994-09-29
K940132	Podiatric Material	Crown Delta Corp.	MNE	Class I	1994-09-29
K934848	Master Alert	Master Hydro Systems, Inc.	FIP	Class II	1994-09-29
K933842	Klein Rectal Tampnade Balloon	Cook Incorporated	KNT	Class II	1994-09-29
K933545	Siemens Fluid Delivery System, Mmt-9500	Siemens Infusions Systems	FRN	Class II	1994-09-29
K931909	Clear Image Sterile Diagnostic Ultrsound Gel	Sonomed Technology, Inc.	IYO	Class II	1994-09-29
K931908	Sonoquick Ultrasound Gel	Sonomed Technology, Inc.	IYO	Class II	1994-09-29
K931304	Ohmeda Hand Held Oximeter	GE Healthcare	DQA	Class II	1994-09-29
K930915	Fluori Methane Ss- a Vapocoolant/skin Ref. Device	Gebauer Co	MLY	Unclassified	1994-09-29
K930735	Lordex Lumbar Extension Machine	Lordex, Inc.	ISD	Class II	1994-09-29
K922452	Gore-Tex Soft Tissue Patch Plus	W. L. Gore & Associates, Inc.	FTL	Class II	1994-09-29
K944465	Carrier, Ligature (79 Gej)	Endotec, Inc.	GCJ	Class II	1994-09-28
K944373	Spectacle Frames	Custom Optical Frames, Inc.	HQZ	Class I	1994-09-28
K944160	Silhouette, Sunlimeted,adidas	Silhouette Optical Ltd.	HQZ	Class I	1994-09-28
K942846	Acufex(r) Endo-Femoral Aimer	Acufex Microsurgical, Inc.	HRX	Class II	1994-09-28
K942834	Acufex Uni-Cut 4. Omm Carpal Tunnel Cannula	Acufex Microsurgical, Inc.	HRX	Class II	1994-09-28
K942611	Foundation All Poly Cup	Encore Orthopedics, Inc.	JDI	Class II	1994-09-28
K942574	Grasper, Dissector, Forceps, Needle Holder	Acufex Microsurgical, Inc.	GCJ	Class II	1994-09-28
K942115	Infinity Revision Hip Stem	Wrightmedicaltechnologyinc	LPH	Class II	1994-09-28
K942079	Manual Surgical Instruments	Acufex Microsurgical, Inc.	HRX	Class II	1994-09-28