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 2026-10-08, 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 3454 of 3526

510(k) clearances, page 3454 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780154	Needleholder, Microvasular 5 1/2	Edward Weck, Inc.	HNM	Class I	1978-03-17
K780121	Reagents, Manueal, Assay, Thyroxine	Syva Co.	CDX	Class II	1978-03-17
K780021	Urine Screening Kits	Diagnostic Culture System	JXA	Class I	1978-03-17
K772362	Avf Set for Single Needle Hemodialysis	Terumo America, Inc.	FIE	Class II	1978-03-17
K770527	Candida Immunodiffusion Kit	I M, Inc.	GMI	Class II	1978-03-17
K780384	Improved Dycal	L.D. Caulk Co.	EJK	Class II	1978-03-15
K780375	Pavlik Harness	Zimmer GmbH	IOZ	Class I	1978-03-15
K780338	Minystag Mn-1	Lkb Instruments, Inc.	DSF	Class I	1978-03-15
K780284	Tibial Plateu	Depuy, Inc.	MBV	Class II	1978-03-15
K780280	Balloon Pump	Datascope Corp.	DSP	Class II	1978-03-15
K780239	Bracket, Metal Reinforced Plastic	Ormco Corp.	DYW	Class II	1978-03-15
K780238	Pacemaker, Prolith 23U. Pulse Generator	Edwards Pacemaker Systems	DXY	Class III	1978-03-15
K780227	Bandage Spreader Block	Zimmer GmbH	ILZ	Class I	1978-03-15
K780217	Anteriors and Posteriors, Plastic	Dentsply Intl.	ELM	Class II	1978-03-15
K780187	Nail, Massie II	Howmedica Corp.	JDO	Class II	1978-03-15
K780170	Orthodontic Bracket Pads	Rocky Mountain Orthodontics, Inc.	EJF	Class I	1978-03-15
K780164	Rtv Dental Silicone	Tydont, Inc.	ELW	Class II	1978-03-15
K780125	Fluoresoft	Holles Laboratories, Inc.	KYC		1978-03-15
K780046	Ultrasphyg Blood Pressure Option	Cavitron Corp.	DXN	Class II	1978-03-15
K772290	Dialyzer, Capilatory, Hollow Fiber	Redy Laboratories	FJI	Class II	1978-03-15
K780382	Audiometer, Portable, Air Conduction	Maico Hearing Instruments, Inc.	EWO	Class II	1978-03-14
K780377	Pinidentoflex Dental Polisher	Cavitron Corp.	EHL	Class I	1978-03-14
K780376	Minidentoflex New Polishing System	Cavitron Corp.	EHL	Class I	1978-03-14
K780369	Modumed Muge	Medtronic, Inc.	JWM	Class II	1978-03-14
K780368	Modumed Mugx	Medtronic, Inc.	JWM	Class II	1978-03-14
K780349	Vaginal Retractor	Edward Weck, Inc.	HDL	Class I	1978-03-14
K780328	Pulmonary Function Tester, Computerized	Warren E. Collins, Inc.	BZC	Class II	1978-03-14
K780326	Ge Ct/t 8800 System	General Electric Co.	JAK	Class II	1978-03-14
K780324	Capnometer Model 47210A	Hewlett-Packard Co.	CCK	Class II	1978-03-14
K780322	Analyzer, Pulmonary Function	Hospal Medical Corp.	BZC	Class II	1978-03-14
K780319	Orbitome-Ug	Philips North America LLC	IZF	Class II	1978-03-14
K780313	Hitachi Tech-Moble Dhc-121	Philips North America LLC	IZL	Class II	1978-03-14
K780293	Electrosurgical Unit	Ritter GmbH	HAM	Class II	1978-03-14
K780260	Temp. Sensor W/22mm Fittings	BD Becton Dickinson Vacutainer Systems Preanalytic	KPD	Class II	1978-03-14
K780216	Lifesaver, Manual #5160	Hudson Oxygen Therapy Sales Co.	BTM	Class II	1978-03-14
K780090	Dental Alloy	Krupp International, Inc.	EJH	Class II	1978-03-14
K772276	Raised Toilet Seat	Med Fusion Systems, Inc.	LDQ		1978-03-14
K772275	Toilet Safety Rail	Med Fusion Systems, Inc.	LDQ		1978-03-14
K780333	Gas Chromatography Head Space Samp. Hs6	Revvity Health Sciences, Inc.			1978-03-09
K780265	Flow Reducing Angulation Stand	Chesebrough-Pond'S U.S.A. Co.	BWF	Class II	1978-03-09
K780264	Nebulization Kit & Adapter Kit	Chesebrough-Pond'S U.S.A. Co.	CAF	Class II	1978-03-09
K780254	Denture Cleanser & Toothpaste in One	Richardson Merrel, Inc.	JER	Class I	1978-03-09
K780237	Disposable Controlled Drop Pasteur Pipet	Owens-Illinois, Inc.	GJG	Class I	1978-03-09
K780195	Wheelchair Muff	Orthopedic Equipment Co., Inc.	KNO	Class I	1978-03-09
K780172	Triglyceride Instrument Application	Harleco	CDT	Class I	1978-03-09
K780141	Ultrazyme Plus Amyl, Centrifichem Appli.	Harleco	CIJ	Class II	1978-03-09
K780100	Ultrazyme Plus Ck-1	Harleco	CGS	Class II	1978-03-09
K780099	Ultrazyme Plus Gt	Harleco	JPZ	Class I	1978-03-09
K780083	Analyzer, Selective, Electronic	Johns Scientific, Inc.	JJE	Class I	1978-03-09
K772395	Davis Rhytidectomy	Edward Weck, Inc.	FZI	Class II	1978-03-09