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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3314 of 3528

510(k) clearances, page 3314 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K803246	Ultrasonic Stethoscope	Sonicaid, Inc.	IYN	Class II	1981-01-28
K803243	Serocluster Flexible Vinyl U & V Pl.	Corning Costar Corp.	JTC	Class I	1981-01-28
K803242	Serocluster Eia Plates	Corning Costar Corp.	JTC	Class I	1981-01-28
K803241	Histological Embedding Media	Miles Laboratories, Inc.	KEO	Class I	1981-01-28
K803236	Cybrex Valproic Acid	Abbott Medical	LEG	Class II	1981-01-28
K803210	Menstrual Aspiration Kits	Gynemetrics, Inc.	HHK	Class II	1981-01-28
K803189	Sunscene Tanning Studio	Sunscene Tanning Studio	LEJ	Class II	1981-01-28
K803181	Scanner, Computerized Tomographic	General Electric Co.	JAK	Class II	1981-01-28
K803162	X-Ray Stand & Operating Chair	Downs Surgical, Ltd.	IYB	Class I	1981-01-28
K803153	Elastic Adhesive Bandages	Abco Dealers, Inc.	KGX	Class I	1981-01-28
K803132	Herpes Simplex Virus Serological Reagent	Microbiological Research Corp.	GQL	Class II	1981-01-28
K803130	Multix U. Bucky Table X-Ray Unit	Siemens Corp.	KPR	Class II	1981-01-28
K803116	Heavy Drainage Pack	American Medical Disposable, Inc.	GEC	Class I	1981-01-28
K803078	Simplicity Infusion Pump Model 2100A	Critikon Company, LLC	FRN	Class II	1981-01-28
K802886	Nucli-Pap Tm-(I125)-Pap Radioimmunoas-	Nuclear Diagnostics, Inc.	JFH	Class II	1981-01-28
K802882	Hydrocolloid Compatible Cream Alginate	Buffalo Dental Mfg Co Inc	ELW	Class II	1981-01-28
K802856	Miniature Ion Selective Electrodes	Ionetics, Inc.	JFP	Class II	1981-01-28
K810110	Cobbler's Chip Splints	Secol Co.	LGF	Class I	1981-01-26
K810109	Metal Splints	Secol Co.	ILH	Class I	1981-01-26
K810107	Respa-Trol	Intensive Technology, Inc.	JJS	Class I	1981-01-26
K810091	Glucose Standard	Anco Medical Reagents & Assoc.	JIS	Class II	1981-01-26
K810090	Cholesterol Reagent	Anco Medical Reagents & Assoc.	CGO	Class I	1981-01-26
K810089	6% Ortho Loliudine Reagent in Glacid Aci	Anco Medical Reagents & Assoc.	CGE	Class II	1981-01-26
K810084	Magnesium Kit	Bio-Analytics Laboratories, Inc.	JGJ	Class I	1981-01-26
K810082	Alkaline Phosph., Liquid Enzy., Kin. Kit	Bio-Analytics Laboratories, Inc.	CJE	Class II	1981-01-26
K810064	Pulsarii, High Volt. Galvanic Musc. Stim	Bomed Medical Mfr., Ltd.	IPF	Class II	1981-01-26
K810063	Automatic Biochemical Analyzer	Acculab	JQP	Class I	1981-01-26
K810062	Bi-Centric Bi-Polar Endoprosthesis	Howmedica Corp.	KWY	Class II	1981-01-26
K810022	Srd III	Dynatech Corp.	JTC	Class I	1981-01-26
K810004	Sterile Disposable Instrument Trays	Ascep, Inc.	FSM	Class I	1981-01-26
K803276	Ana-Ifa Test System	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1981-01-26
K803274	Automated Immunoprecipitin Method/iga	Icl Scientific	CZP	Class II	1981-01-26
K803272	Automated Immunoprecipitin Method/icg	Icl Scientific	DFZ	Class II	1981-01-26
K803251	Aip System-Method for Igm	Icl Scientific	DFT	Class II	1981-01-26
K803248	Ames Sera-Pak Hemoglobin Reagent	Miles Laboratories, Inc.	KHG	Class II	1981-01-26
K770791	Depilator, Derma-I & Derma-II	Electro-Kinetic Eng/Mfg	KCX	Class I	1981-01-26
K810061	Curved Sherman Bone Plate	Howmedica Corp.	HRS	Class II	1981-01-23
K810057	Galvanator 725	Avratronics Corp.	IPF	Class II	1981-01-23
K810035	Prenatal Support Pillow	Supportech, Inc.	CCX	Class I	1981-01-23
K810024	Bonner Brace	Bee Ent.	IQK	Class I	1981-01-23
K810021	Flo-Temp	Laminar Flow Industries	FLA	Class II	1981-01-23
K810019	Surg-Flex 15 Surgical Light	Medical Products Development, Inc.	FSQ	Class II	1981-01-23
K810018	Surg-Flex 5 Surgical Light	Medical Products Development, Inc.	FSQ	Class II	1981-01-23
K803192	Hcl Acetabular Components	Osteonics Corp.	KWZ	Class II	1981-01-23
K803191	Prosthesis, Hip Femoral Component Metal	Osteonics Corp.	KWL	Class II	1981-01-23
K803111	Erectaid	Burditt & Calkins-Siemens-Elema	FAE	Class II	1981-01-23
K802806	Visecera Retainer	Adept-Med Intl., Inc.	GCZ	Class I	1981-01-23
K810068	Pediatric Arterial Blood Filter	Delta Medical Industries	DTM	Class II	1981-01-22
K803315	Criterion II Rhythm Profile Monitor	Dart Medical Equipment	DXH	Class II	1981-01-22
K803257	Csg-Flow Control Valve	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1981-01-22