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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2812 of 3530

510(k) clearances, page 2812 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871471	Capillary Flow Dialyzers Models St-12 & St-15	Travenol Laboratories, S.A.	FJI	Class II	1987-06-12
K871371	Digital Sphygmomanometer	Omron Tateisi Electronics Co.	DRS	Class II	1987-06-12
K871348	Sharplan Medilas Model 40 N for Urological Use	Sharplan Lasers, Inc.	LNK	Class II	1987-06-12
K871152	Sigma's Calcium Procedure No. 587	Sigma Diagnostics, Inc.	CIC	Class II	1987-06-12
K871077	Model Cbc-1 Coa Comp Anti-Sticking Bipolar Coag.	Radionics, Inc.	GEI	Class II	1987-06-12
K870840	Model 20-C W/br-20A/u Attach/model Hl-3.O Attach	Directed Energy, Inc.	EWG	Class II	1987-06-12
K870356	Tatch-It	Reunion Medical Co.	DRS	Class II	1987-06-12
K863702	Pulse Cuff Recorder Model Pcr100	Imex Medical Systems, Inc.	JOM	Class II	1987-06-12
K872010	Multichem Ldh-L Reagent	Simmler Inc	CFJ	Class II	1987-06-11
K871979	Gamma Glutamyltransferase Reagent	Intersect Systems, Inc.	JPZ	Class I	1987-06-11
K871973	Il Monarch 1000 Clinical Chemistry Analytical Sys.	Instrumentation Laboratory Co.	JJG	Class I	1987-06-11
K871871	Series Ten Thousand Ocutome	CooperVision, Inc.	HQE	Class II	1987-06-11
K871800	Summit Optics Post-Mydriatic Spectacles	Summit Optics, Inc.	HQY	Class I	1987-06-11
K871716	Ultra Maxithins Pads	Tambrands Inc.	HHD	Class I	1987-06-11
K871645	Tdxr Rea(tm) Ethanol	Abbott Medical	DIC	Class II	1987-06-11
K871602	Microcheck Lh Ovulation Test	Syntron Bioresearch, Inc.	CEP	Class I	1987-06-11
K871423	Phenytoin Fpia Calibrators	Sigma Diagnostics, Inc.	DLJ	Class II	1987-06-11
K871409	Vinyl Polysiloxane Impression System	Crown Delta Corp.	ELW	Class II	1987-06-11
K871396	Acculator 287Ep	Accu Science Corp.	GZJ	Class II	1987-06-11
K871308	Allelix Pregnancy Detection Kit 48 Test Kit	Allelix, Inc.	JHI	Class II	1987-06-11
K871304	Lifestyles Extra Strength Condoms W/nonoxynol-9	Ansell, Inc.	HIS	Class II	1987-06-11
K871174	4-9295 Barbiturates Test Mix	Supelco, Inc.	DKB	Class II	1987-06-11
K870414	Quik-Brush	Intl. Medication Systems, Ltd.	EFW	Class I	1987-06-11
K863393	Endocater	The Hygenic Company, LLC	LQY	Unclassified	1987-06-11
K872058	Oricult-N Culture-Paddle	Orion Corp.	JSI	Class I	1987-06-10
K871915	Miniature Temp. Cardiac Pacemakers Ec4542 & Ec4543	Pace Medical	DTE	Class II	1987-06-10
K871748	The Buddy System W/optional ECG Electrode	The Buddy Systems, Inc.	DRX	Class II	1987-06-10
K871668	Biodan Type Comet Electrode	National Medical Technology	DRX	Class II	1987-06-10
K871667	Ureteral Stent	Penn Medical Devices, Inc.	FAD	Class II	1987-06-10
K871643	Conveen(r) Leg-Bag (600 Ml)	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1987-06-10
K871610	Conveen(r) Night Drainage Bag (2000 Ml)	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1987-06-10
K871318	Q.i.c. Bleeding Time Device	Helena Laboratories, Corp.	JCA	Class II	1987-06-10
K871282	Synectics Liberty System Amplifier and Software	Synectics-Dantec	FFT	Class I	1987-06-10
K871268	Rodenstock Scanning Laser Ophthalmoscope	G. Rodenstock Instrumente GmbH	HLI	Class II	1987-06-10
K871192	Subcutaneously Implanted Drug Delivery Depot	Norfolk Medical Products, Inc.	LJT	Class II	1987-06-10
K870945	Rabbit Plasma Fibrinogen Supplement Sr 122	Oxoid U.S.A., Inc.	JTL	Class I	1987-06-10
K870223	Ameda Amelette(r) Neonatal Incubator	Hollister, Inc.	FMZ	Class II	1987-06-10
K870222	Ameda Amecare(r) Neonatal Incubator	Hollister, Inc.	FMZ	Class II	1987-06-10
K864278	Ds-II Digital Sonography System	Intl. Acoustics, Inc.	DQD	Class II	1987-06-10
K871982	Tourniquet Pressure Regulator	Avec Scientific Design Corp.	KCY	Class I	1987-06-09
K871927	Cup Biopsy Forcep, 1.7Mm	Arthropedics, Inc.	GEN	Class I	1987-06-09
K871926	Grasping Forcep, 1.7Mm	Arthropedics, Inc.	GEN	Class I	1987-06-09
K871906	Unimed Surgeon's Gowns	Unimed Hospital Supply Corp.	FYA	Class II	1987-06-09
K871801	Cytotech Antinuclear Antibody (Ana) Ifa Kit	Cytotech, Inc.	DHN	Class II	1987-06-09
K871740	Lyosheet Surgical Sheet for Burns	Acme United Corp.	FPY	Class I	1987-06-09
K871656	Orthomet Austin-Moore System	Orthomet, Inc.	KWL	Class II	1987-06-09
K871019	Enfuse Enternal Administration Set & Pump Set	Entech, Inc.	KNT	Class II	1987-06-09
K870855	Uroscan	Endotherapeutics	FAP	Class II	1987-06-09
K870715	Multi-Flex Table -- Model 106	Slenderizers Equipment Mfg., Inc.	JFB	Class II	1987-06-09
K870714	Multi-Flex Table -- Model 105	Slenderizers Equipment Mfg., Inc.	JFB	Class II	1987-06-09