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 2026-10-19, 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 3038 of 3529

510(k) clearances, page 3038 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843348	Nisonson Wire & Drill Guide Sys	Stryker Corp.			1984-10-31
K843336	Automatic Multiclip Dispos. Ligating	Davis & Geck, Inc.	FZP	Class II	1984-10-31
K843306	Uva Suntanning Units Various Models	Topsolo Sun Systems	FTC	Class II	1984-10-31
K843187	Cannula	Ethicon, Inc	GEA	Class I	1984-10-31
K842710	Concept C-Vac	Concept, Inc.	GCY	Class I	1984-10-31
K842703	Nd-Yag Laser 8000 Neurosurgery Applica	Cooper Lasersonics, Inc.	GEX	Class II	1984-10-31
K841591	Pyro-Tip	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-10-31
K840951	First Aid Bandage	Gainor Medical	KGX	Class I	1984-10-31
K840950	Zinc Oxide Tape	Gainor Medical	KGX	Class I	1984-10-31
K840945	Skin Closure	Gainor Medical	FPX	Class I	1984-10-31
K840609	Skin Tech. Isotex 86L	Lectec Corp.	KGX	Class I	1984-10-31
K840547	Wilcox Rod & Plate Bender	Downs Surgical, Ltd.			1984-10-31
K840448	Medical Adhesive Foam Tape	Lectec Corp.	KGX	Class I	1984-10-31
K840446	Medical Tape	Lectec Corp.	KGX	Class I	1984-10-31
K844084	Polyvinyl Chloride Cannulas	Hudson Extrusions, Inc.	CAT	Class I	1984-10-30
K844083	Straight and Bubble Oxygen Tubing	Hudson Extrusions, Inc.	CAT	Class I	1984-10-30
K844075	Uric Acid Reagent Set	Livonia Diagnostics, Inc.	LFQ	Class I	1984-10-30
K844024	Creatinine Reagent Set	Livonia Diagnostics, Inc.	CGX	Class II	1984-10-30
K844011	Focus Uric Acid	Abbott Medical	KNK	Class I	1984-10-30
K843987	Pyr Broth	Remel Inc	JTO	Class I	1984-10-30
K843938	Linear Enzymatic Uric Acid System	Simmler Inc	KNK	Class I	1984-10-30
K843930	Irma Immunoradiometric Assay-Fsh 125I	Euro-Diagnostics BV	CGJ	Class I	1984-10-30
K843919	Spottest Loeffler Methylene Blue Stain	Difco Laboratories, Inc.	KFC	Class I	1984-10-30
K843916	Tdx Rea Creatinine	Abbott Medical	CGX	Class II	1984-10-30
K843913	Cobas Fp Tdm Controls	Roche Diagnostic Systems, Inc.	DIF	Class I	1984-10-30
K843895	Total Calcium Reagent Set	Livonia Diagnostics, Inc.	CIC	Class II	1984-10-30
K843893	Magnesium Reagent Set	Livonia Diagnostics, Inc.	JGJ	Class I	1984-10-30
K843871	Parathyroid Hormone C-Terminal Ria Kit	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1984-10-30
K843870	Parathyroid Hormone Mid-Molecule Ria-Kit	Siemens Healthcare Diagnostics Inc.	CEW	Class II	1984-10-30
K843818	Human Serum Anticonvulsant Drug Control	Quantimetrix Corp.	DIF	Class I	1984-10-30
K843795	Beta Quik V	Pacific Biotech, Inc.	JHI	Class II	1984-10-30
K843752	Sigma Periodic Acid-Schiff Stain 395	Sigma Chemical Co.	HZT	Class I	1984-10-30
K843668	Photometer 90Iys	Institute Virion, Ltd.	JJQ	Class I	1984-10-30
K843619	Retic-Set	R & D Systems, Inc.	KQC	Class I	1984-10-30
K843590	Detect-a-Strep	Antibodies, Inc.	GTZ	Class I	1984-10-30
K843534	Oral Thc-Cannabinoids Direct Ria Kit	Immunalysis Corporation	LAT	Class II	1984-10-30
K843004	Servo Med Nystagmograph Ng-1	Servo Med, Inc.	GWN	Class II	1984-10-30
K842995	Ema Liv Cenera Dental Cement	Int'L Corp.	EMA	Class II	1984-10-30
K842660	Anti-Schistosoma Species Kit	Amico Lab, Inc.	GNH	Class I	1984-10-30
K841680	Scott Selecticult-Hsv Isolation &	Scott Laboratories, Inc.	GQL	Class II	1984-10-30
K840932	Muse-Dp	Marquette Electronics, Inc.	DXN	Class II	1984-10-30
K840358	Impedance/8200 Monitor-Model 8300	Aequitron Medical, Inc.	KRC	Class II	1984-10-30
K841472	Cardiorhythm 2000	Biogenix, Inc.	DSH	Class II	1984-10-29
K840523	Servomed Pulse Amplifier Module-206-	Litton Medical Electronics	DRT	Class II	1984-10-29
K843890	Custom Instrument Drape	Lifestream Int'L, Inc.	HMW	Class II	1984-10-26
K843830	J -Jamshidi Type-Bone Marrow Biopsy/aspi	Popper & Sons, Inc.	GDM	Class I	1984-10-26
K843503	Aegis Ambulatory Monitoring System	Aegis Medical Systems, Inc.	DSI	Class II	1984-10-26
K842977	Orthopaedic Cable System	Richards Medical Co., Inc.	JDQ	Class II	1984-10-26
K842473	Implantable Programmable Pulse Generat	Telectronics, Inc.	DXY	Class III	1984-10-26
K842213	Vsm R1	Physio Control, Inc.	DXO	Class II	1984-10-26