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 2896 of 3529

510(k) clearances, page 2896 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861392	Syva Solid Phase Columns System II	Syva Co.	KZR	Class I	1986-06-13
K861326	Respisomnograph	Dickstein, Shapiro & Morin	BZQ	Class II	1986-06-13
K861282	Murex Suds Rubella	Murex Corp.	LFX	Class II	1986-06-13
K861186	Sceptor Gram Positive Breakpoint/id Panel	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1986-06-13
K861017	Galenica's Disposable Anoscopes	Galenica Enterprises, Inc.	FER	Class II	1986-06-13
K860548	Model 492-02 Endocardial Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-06-13
K860547	Model 486-02 Endocardial Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-06-13
K855239	Biotel (Tm)/ Diabetes	American Diagnostic Corp.	JIL	Class II	1986-06-13
K854765	Insta-Tooth Splint Bar with & without Teeth	C&C Systems, Inc.	EHP	Class I	1986-06-13
K853989	Cor Dot Cmv	Cordis US Corp.	GQI	Class II	1986-06-13
K853872	Emit Caffeine Assay	Syva Co.	KLS	Class II	1986-06-13
K861498	Medtronic Model 8501 Access Port	Medtronic, Inc.	LJT	Class II	1986-06-12
K861001	Parenteral Infuser Medipump 204	Medix Medical Electronics (U.S.A.), Inc.	FRN	Class II	1986-06-12
K860848	Vital Flow Nasal CPAP System	Systems 2000, Inc.	BYE	Class II	1986-06-12
K853608	Neurometer	Neurotron Inc	LLN	Class I	1986-06-12
K861930	Cm-6 Total Hip System	Kirschner Medical Corp.	JDI	Class II	1986-06-11
K861819	Kodak Ektachem Clinical Chemistry Slides (Crea)	Eastman Kodak Company	CGX	Class II	1986-06-11
K861700	Dimension (Tm) Clinical Chemistry System	E.I. Dupont de Nemours & Co., Inc.	CHH	Class I	1986-06-11
K855017	Lsf* Total Hip System	Implant Technology, Inc.	JDI	Class II	1986-06-11
K862062	Nonwoven Surgical Drape Pack	East Texas Lighthouse for the Blind	KKX	Class II	1986-06-10
K862049	Mentor Flat-Span	Mentor	LCJ	Unclassified	1986-06-10
K861997	Penicillin-Streptomycin-Fungizone Mixture	Hazleton Research Products, Inc.	JSK	Class I	1986-06-10
K861978	Autofluor V	Technia Diagnostics, Ltd.	KTL	Class II	1986-06-10
K861637	Weighted Acquisition Module	Siemens Gammasonics, Inc.	IYX	Class I	1986-06-10
K861631	Slide Culture U 'Eiken'	Syn-Kit, Inc.	JXA	Class I	1986-06-10
K861516	Welch Allyn Tympanometer	Welch Allyn Inc	ETY	Class II	1986-06-10
K861161	Surgi-Tie Loops	Healthmed Corp.			1986-06-10
K860760	Erbium X-Ray Filter	Reactor Experiments, Inc.	ITY	Class I	1986-06-10
K860550	Du Pont C-Reactive Protein (Crp) Assay	E.I. Dupont de Nemours & Co., Inc.	DCK	Class II	1986-06-10
K860549	Du Pont C-Reactive Protein (Crp) Calibrator	E.I. Dupont de Nemours & Co., Inc.	DCK	Class II	1986-06-10
K854485	Rich-Mar If 200	Rich-Mar Corp.	IPF	Class II	1986-06-10
K862034	Jedmed Ccd-02 Video Camera System	JEDMED Instrument Company	FWD	Class I	1986-06-09
K862012	Ladd Medical S-2000	Ladd Research Industries, Inc.	GWM	Class II	1986-06-09
K862010	Chick Surgical Light	Professional Medical Products, Inc.	FTA	Class II	1986-06-09
K861996	Dulbecco's Mem with 4.5 G/l Glucose Medium	Hazleton Research Products, Inc.	KIT	Class I	1986-06-09
K861992	Model 43200A Cardiac Monitor	Hewlett-Packard Co.	DPS	Class II	1986-06-09
K861989	Modification of Suntana Sun System Bed	Hawaiian Tan SpA	FTC	Class II	1986-06-09
K861965	Unitek Ceramic Bracket System	Unitek Corp.	DYW	Class II	1986-06-09
K861960	Zimlite Lens	Asahi Optical Co. C/O Rosati Associates, P.C.	HQG	Class I	1986-06-09
K861934	Saliva Ejector	Carlisle Laboratories, Inc.	DYN	Class I	1986-06-09
K861928	Sterile O. R. Towel	Anago, Inc.	IXX	Class II	1986-06-09
K861902	Kotex Profile Shaped Maxi Pad	Kimberly-Clark Corporation	HHD	Class I	1986-06-09
K861857	Phonic Ear	Phonic Ear, Inc.	ETW	Class II	1986-06-09
K861838	Polypole	Poly Medical Technologies, Inc.	FOX	Class I	1986-06-09
K861825	Corneal Transplant Trephine Disposable Blade	Storz Instrument Co.	HRH	Class I	1986-06-09
K861759	Girard Sunglasses (Non-Prescription)	H. Girard S.A.	HQG	Class I	1986-06-09
K861744	Sapphire Knife Blade	Keeler Instruments, Inc.	HNN	Class I	1986-06-09
K861739	Tec Portamax H.v. Pulsed Galvanic Stimulator	J.A. Preston Corp.	IPF	Class II	1986-06-09
K861723	(Modified) Omnifit Threaded Acetabular Component	Osteonics Corp.	KWA	Class III	1986-06-09
K861684	Seiko P-2 & Seiko P-3 (Spectacle Lens)	Seiko Optical Products of America, Inc.	HQG	Class I	1986-06-09