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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3512 of 3526

510(k) clearances, page 3512 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760988	Dental Handpieces	Adp Intl., Inc.			1976-11-15
K760987	Diamond Stones	Adp Intl., Inc.	DZP	Class I	1976-11-15
K760986	Carbide Dental Burs	Adp Intl., Inc.	EJL	Class I	1976-11-15
K760985	Hand Instruments	Adp Intl., Inc.	EKW	Class I	1976-11-15
K760984	Orthodontic Instruments	Adp Intl., Inc.	JEX	Class I	1976-11-15
K760983	Endodontic Instruments	Adp Intl., Inc.	EKN	Class I	1976-11-15
K760982	Dental Varnish	Adp Intl., Inc.	LBH	Class II	1976-11-15
K760981	Alginate Impression Material	Adp Intl., Inc.	ELW	Class II	1976-11-15
K760980	Dental Alloy	Adp Intl., Inc.	EJJ	Class II	1976-11-15
K760979	Composite Material	Adp Intl., Inc.	EBF	Class II	1976-11-15
K760978	Zinc Cement	Adp Intl., Inc.	EMA	Class II	1976-11-15
K760959	Surgical Chisel	American Safety Equipment Corp.	EMM	Class I	1976-11-15
K760957	Surgical Reciprocating Saw	American Safety Equipment Corp.	DZH	Class II	1976-11-15
K760271	Electrocardiograph, Ek-7 (3-Channels)	Burdick Corp.	DPS	Class II	1976-11-15
K760961	Occlusion Clips	Cerenovus, Inc.	HCH	Class II	1976-11-12
K760913	Microtyne Unit	Transmed, Inc.	IPF	Class II	1976-11-12
K760854	Three-Channel Stress Test System (M633)	Quinton, Inc.	DPS	Class II	1976-11-12
K760844	Cardiac Output Computer (Model Coc-100)	B-D Electrodyne	DXG	Class II	1976-11-12
K760843	Paley Transparent Manifold	Usci, Div. C.R. Bard, Inc.	DTL	Class II	1976-11-12
K760824	Tmo Total Bypass Membrane Oxygenator-I	Travenol Laboratories, S.A.	DTZ	Class II	1976-11-12
K760823	Tmo Oxygenator Reservoir Pump Set	Travenol Laboratories, S.A.	DTN	Class II	1976-11-12
K760671	Pacemakers, Vitatrons (Series 3000)	Vitatron Medical BV	DXY	Class III	1976-11-12
K760670	Pacemakers, Vitatrons (Series 2000)	Vitatron Medical BV	DXY	Class III	1976-11-12
K760669	Pacemakers, Vitatron's	Vitatron Medical BV	DXY	Class III	1976-11-12
K760586	Suction Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	JOL	Class II	1976-11-12
K760560	Cath Care Kit	Walpak Co.	KGO	Class I	1976-11-12
K760554	Apparel, Barrier Scrub	Surgikos, Inc.	FYA	Class II	1976-11-12
K760552	Thermometer Stand and Dust Cover	Landmark Plastics	FLK	Class II	1976-11-12
K760548	Carafe and Liner	Landmark Plastics			1976-11-12
K760545	Weighing Station, Mobile Patient	Gaymar Industries, Inc.	FRW	Class I	1976-11-12
K760521	Tape Measure	Mcgaw Laboratories	KTZ	Class I	1976-11-12
K760520	Calipers, Mcgaw Skinfold	Mcgaw Laboratories	BXW	Class I	1976-11-12
K760517	Cup, Disposable Medicine	Landmark Plastics	KYX	Class I	1976-11-12
K760507	Forcep, Thumb	Acme United Corp.	GEN	Class I	1976-11-12
K760497	Tray, Service	Landmark Plastics	LRP	Class I	1976-11-12
K760496	Cup, Disposable Specimen	Landmark Plastics	FMH	Class I	1976-11-12
K760495	Basin, Rectangular Wash	Landmark Plastics	FNY	Class I	1976-11-12
K760494	Basin, Round Wash	Landmark Plastics	FNY	Class I	1976-11-12
K760493	Dish, Soap	Landmark Plastics			1976-11-12
K760492	Basin, Large or Small	Landmark Plastics	FNY	Class I	1976-11-12
K760490	Bedpan, General Medical Medi-Pak	Landmark Plastics	FOB	Class I	1976-11-12
K760336	Biocept-G	Wampole Laboratories	JHI	Class II	1976-11-12
K760272	Circuit, Printed, Servo-Mechanism	Burdick Corp.	DPS	Class II	1976-11-12
K760268	Electrocardiograph Ek-6 W/optional Circ.	Burdick Corp.	DPS	Class II	1976-11-12
K760950	Devon Knee Strap	Devon Industries, Inc.	IQI	Class I	1976-11-11
K760949	Charles Irrigating Fundus Contact Lens	Richard'S Medical Equip., Inc.	HJI	Class I	1976-11-11
K760933	Barrier Universal Sheet	Surgikos, Inc.	KKX	Class II	1976-11-11
K760932	Boundary Fabric III Surgical Drape	Procter & Gamble Mfg. Co.	KKX	Class II	1976-11-11
K760924	Tucks Polypad Maternity Care Pad	Parke-Davis Co.	HHD	Class I	1976-11-11
K760911	Breast Care Kit	American Hospital Supply	HGY	Class I	1976-11-11