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 2238 of 3531

510(k) clearances, page 2238 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935480	Medical Specialties Non-Coring Needle Admin Sets	Evans Medical, Inc.	FMI	Class II	1994-01-28
K935357	Snap Reciprocating Saw	Surgiquip, Inc.	GAF	Class I	1994-01-28
K935322	Snap Bone Reamer	Surgiquip, Inc.	HWE	Class I	1994-01-28
K934973	Hela-229/Hela Cells	Advanced Clinical Diagnostics	KIR	Class I	1994-01-28
K934934	Rabbit Kidney Cells - R.k.c.	Advanced Clinical Diagnostics	KIR	Class I	1994-01-28
K934908	Full View Digital Storage System	International Imaging Electronics	IYO	Class II	1994-01-28
K934889	Olympus Imagemanager System	Olympus Corp.	LMB	Class I	1994-01-28
K934625	Lorad M-III	Lorad Corp.	IZH	Class II	1994-01-28
K934526	Micro-Sp Custom Spinal Anesthesia Tray	Neurodelivery Technology, Inc.	CAZ	Class II	1994-01-28
K934259	Ac-Powered Medical Examination Light	Welch Allyn Inc	KZF	Class I	1994-01-28
K933996	Profiblot	Tecan U.S.	KPA	Class I	1994-01-28
K933973	N-Assay Tia Multi V-Nl	Crestat Diagnostics, Inc.	CFN	Class II	1994-01-28
K933832	Electromedics Hg (Hydrogel) Series Skin Temperature Sensor	Electromedics, Inc.	FLL	Class II	1994-01-28
K933726	Modification of Bair Hugger Patient Warming System	Augustine Medical, Inc.	LHC	Class I	1994-01-28
K933712	El-RF Test System: El-RF-Igm Kit	Theratest Laboratories, Inc.	DHR	Class II	1994-01-28
K933242	Sofamor Orthopaedic Instruments	Danek Medical, Inc.	LXH	Class I	1994-01-28
K932991	Guardian and Andino Models	Coltemp, Inc.	FLK	Class II	1994-01-28
K932829	Centrix's Encore Natural Composite Resin Core Past	Alpha-Dent	EBF	Class II	1994-01-28
K932826	Centrix's Encore Composite Resin Core Paste W\fluo	Alpha-Dent	EBF	Class II	1994-01-28
K932790	Thermal Option	Cox Medical Ent., Inc.	KGE	Class II	1994-01-28
K932653	Swisstek 2000(Tm) Cast Removal System	Carapace, Inc.	LGH	Class I	1994-01-28
K931395	Series 5000 Battery Powered Instrument System	Micro Surgical Instruments Corp.	KIJ	Class I	1994-01-28
K931250	Phyne-Touch Pf	Medical Resources, Ltd.	LYY	Class I	1994-01-28
K930822	Gore-Tex Soft Tissue Patch,surgical Membrane,mesh	W. L. Gore & Associates, Inc.	FTL	Class II	1994-01-28
K930069	Bipolar Balloon Pacing Catheter by J-Lloyd	J-Lloyd Medical, Inc.	LDF	Class II	1994-01-28
K936187	Lspi Pressure Regulator	Life Support Products, Inc.	CAN	Class I	1994-01-27
K935559	Hearing Aids Hb-36M, Hb-36Ms, Hb-36Mt, Hi-67P, Excel-1000	Rockwin Corp.	ESD	Class I	1994-01-27
K935516	Snap Drill	Surgiquip, Inc.	HWE	Class I	1994-01-27
K935502	Event Test Strip Hcg	Boehringer Mannheim Italia SpA	JHI	Class II	1994-01-27
K935501	Scimed Viper Pta Catheter with Bioslide Hydrophilic Coating	Scimed Peripheral Interventions	LIT	Class II	1994-01-27
K935362	P-Amylase Control	Beckman	JJX	Class I	1994-01-27
K935343	Centrifiq Blood Control	Hematronix, Inc.	JPK	Class II	1994-01-27
K935181	Aspartate Aminotransferase (Ast) Test	Em Diagnostic Systems, Inc.	CIT	Class II	1994-01-27
K935101	Urine Calibrators and Controls Modification	Diagnostic Reagents, Inc.	DKB	Class II	1994-01-27
K935062	Mas Liquid Urinalysis Control	Medical Analysis Systems, Inc.	JJW	Class I	1994-01-27
K934599	Sandman	Melville Software, Ltd.	OLV	Class II	1994-01-27
K934431	Pneumatic Wire Tensioner	Smith & Nephew Richards, Inc.	HSZ	Class I	1994-01-27
K934422	Nasopharyngoscope	Marks & Murase	EOB	Class II	1994-01-27
K934380	Pasco Mic Panels/ Gent & Strep Synergy	Pasco Laboratories, Inc.	JWY	Class II	1994-01-27
K933886	Toa Medical Electronics Ca-5000	Toa Medical Electronics USA, Inc.	JPA	Class II	1994-01-27
K933699	Geister Surgical Int'l Bipolar Endoscopic Surgical Instruments	Geister Medizin Technik GmbH	GEI	Class II	1994-01-27
K933584	Sacred Crane Tdp	Telstar Innovations, Inc.	ILY	Class II	1994-01-27
K933382	Imc Cable/wire Cover	Inman Medical Corp.	KKX	Class II	1994-01-27
K933067	Probes,scissors,forceps,graspers,&needle Holders	MEDLINE INDUSTRIES, LP - Northfield	GCJ	Class II	1994-01-27
K933063	Isotechnologies Back Tracker and Back Works Softwa	Isotechnologies, Inc.	KQX	Class I	1994-01-27
K932874	Blood Gas Mixture	Tri-Gas, Inc.	BXK	Class I	1994-01-27
K932849	Pmi TENS Electrode	Pepin Mfg., Inc.	GZJ	Class II	1994-01-27
K932391	Navarre Biomedical Universal Drainage Catheter Set	Navarre Biomedical, Ltd.	GBX	Class I	1994-01-27
K931769	Snap Oscillating Saw	Surgiquip, Inc.	GFA	Class I	1994-01-27
K931736	M-Flex 5000 C3pmd	Medical Systems Corp.	BXB	Class I	1994-01-27