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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2848 of 3529

510(k) clearances, page 2848 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864472	Person to Person Valve-Mask & Tri-Seal Face Mask	Tagg Industries	CBP	Class II	1987-01-12
K864431	Pediatric Bellows	Draeger, Inc.	CBK	Class II	1987-01-12
K864233	Bard Harvard Mini-Infuser 950 Pump	C.R. Bard Inc	FRN	Class II	1987-01-12
K864218	Procon	Healthcare Management Systems	KNT	Class II	1987-01-12
K864009	Mingograf 410	Siemens Medical Solutions USA, Inc.	DPS	Class II	1987-01-12
K863959	Ohmeda 6000 Multi-Gas Monitor	GE Healthcare	JJQ	Class I	1987-01-12
K863801	Tmm Model 3000 Anesthesia Circuit Evaluator	Traverse Medical Monitors	CBS	Class II	1987-01-12
K863410	Patient Valve with Air Entrainment	Pneupac, Ltd.	BTL	Class II	1987-01-12
K863154	Heated Jet Humidifier Model Ams-1020	Acutronic Medical Systems AG	BTT	Class II	1987-01-12
K862085	Arkive (Tm)	Diatek, Inc.	BSZ	Class II	1987-01-12
K860036	Edp-20 Pacemaker	Biotronik Sales, Inc.	DXY	Class III	1987-01-12
K865014	Liquichek Immunology Control (Human) Levels I & II	Bio-Rad	DGR	Class I	1987-01-09
K864974	General Purpose Centrifuge	Norfolk Scientific, Inc.	JQC	Class I	1987-01-09
K864966	Estrone Analysis Products Radioimmunoassay Estrone	Diagnostics Biochem Canada, Inc.	CGF	Class I	1987-01-09
K864894	Easy-Test Alcohol (Alc), Item No. 67515/93	Em Diagnostic Systems, Inc.	DMT	Class II	1987-01-09
K864865	Speculum, Vaginal, Metal Fiberoptic	Luxtec Corp.	HDG	Class I	1987-01-09
K864850	Wako(tm) Autokit Gpt	FUJIFILM Healthcare Americas Corporation	CKA	Class I	1987-01-09
K864741	Cresolphthalein Complexone, Calcium	Tech-Co, Inc.	CIC	Class II	1987-01-09
K864680	Mobil 02	Roman Laboratories, Inc.	BTI	Class II	1987-01-09
K864546	Maxi-Tan Device	National Biological Corp.	FTC	Class II	1987-01-09
K864373	Clearblue Pregnancy Testing Kit (Modification)	Unipath, Ltd.	LCX	Class II	1987-01-09
K864336	Pachymeter System V	CooperVision, Inc.	IYO	Class II	1987-01-09
K864323	Cytology Brushes	Medical Packaging Corporation	HHT	Class II	1987-01-09
K864312	Ic Microassay	Diamedix Corp.	DAK	Class II	1987-01-09
K864285	Terumo Ovation Spectrophotometer	Terumo Medical Corp.	JJQ	Class I	1987-01-09
K864277	Unimax Ite & Ultramax-Ccr Custom Canal Instruments	Unimax Hearing Instruments	ESD	Class I	1987-01-09
K864267	Sep-Pak Cartridges (Liquid Chromatography)	EMD Millipore Corporation	DPM	Class I	1987-01-09
K863999	Vis-Cube Pregnancy Home Test,cat. # Jpl-042	Leeco Diagnostics, Inc.	LCX	Class II	1987-01-09
K863947	Sonolayer-L, Sal-77B	Toshiba Medical Systems	IYO	Class II	1987-01-09
K862866	Model 10-C W/lp-10A/u & Os-10A/u for Oral/ent Use	Directed Energy, Inc.	EWG	Class II	1987-01-09
K862865	Model 10-C W/lp-10A/u & Ob-10A/u for Oral/ent Use	Directed Energy, Inc.	EWG	Class II	1987-01-09
K861202	Tru-Level Control Immunoassay Controls	Nms Pharmaceuticals, Inc.	JJY	Class I	1987-01-09
K864851	Model Force 100 Bipolar Electrosurgical Generator	Medtronic, Inc.	GEI	Class II	1987-01-08
K864816	Ck 5000 Series, Ace Bandage/esmark Bandage	Currie Medical Specialties, Inc.			1987-01-08
K864786	Personally(tm), Model 241 Sizes 0-12,Left & Right	MEDLINE INDUSTRIES, LP - Northfield	GBI	Class I	1987-01-08
K864785	Amoena Breast Forms	MEDLINE INDUSTRIES, LP - Northfield	GBI	Class I	1987-01-08
K864675	Model Force 4B Electrosurgical Generator	Medtronic, Inc.	GEI	Class II	1987-01-08
K864607	Easy-Test Quinidine Item No. 67---/95	Em Diagnostic Systems, Inc.	LBZ	Class II	1987-01-08
K864553	Easy-Test Carbamazepine Item No. 67---/95	Em Diagnostic Systems, Inc.	KLT	Class II	1987-01-08
K864926	Emds Tm Phenobarbital(phno) Testpack, #67677/95	Em Diagnostic Systems, Inc.	DLZ	Class II	1987-01-07
K864925	Emds Tm Phenytoin (Ptn) Testpack, Item #67676/95	Em Diagnostic Systems, Inc.	DIP	Class II	1987-01-07
K864677	Tsh Maiaclone Immunoradiometric Assay Kit/mag Sep	Serono Diagnostics, Inc.	JLW	Class II	1987-01-07
K864554	Easy-Test Primidone Item No. 67---/95	Em Diagnostic Systems, Inc.	DIP	Class II	1987-01-07
K864527	Duoceph	Gary E. Hall, Dds	IWY	Class I	1987-01-07
K864346	Rembrandt Porcelain Tinting Kit	Den-Mat Corp.	EBF	Class II	1987-01-07
K864321	Micro-Vent	Core-Vent Corp.	DZE	Class II	1987-01-07
K863918	Minolta/marquest Pulsox-7 Oxygen Saturation Monit.	Marquest Medical Products, Inc.	DQA	Class II	1987-01-07
K863610	The Ob-Gyn Concepts Vaginal Aspirator	Ob/Gyn Concepts, Ltd.	KOH	Class I	1987-01-07
K862916	Ez-Screen: Cannabinoid	Environmental Diagnostics, Inc.	KLT	Class II	1987-01-07
K862315	Fyodorov Collagen Corneal Shield	Medical Technology Development Corp.	MOE	Class I	1987-01-07