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 2869 of 3529

510(k) clearances, page 2869 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863034	Sharpoint Stainless Steel Suture	Chathamborough Research Group, Inc.	GAO	Class II	1986-09-30
K862814	Complement-Fixation Test for Campylobacter Jejuni	Institute Virion, Ltd.	LQP	Class I	1986-09-30
K854533	Single Channel Brain Stem Response Audiometer Bsr2	Madsen Electronics (Canada), Ltd.			1986-09-30
K863696	Arthroscopic Surgical Power Device	American Edwards Laboratories	KIT	Class I	1986-09-29
K863661	Medcomp Disposable Manifold System	Medical Components, Inc.	DTL	Class II	1986-09-29
K863639	Articular Motion Device (Amd4000)	Med Surg Designs, Inc.	BXB	Class I	1986-09-29
K863637	Updated Sterile Gowns, Masks and Towels	Biological & Environmental Control Laboratories			1986-09-29
K863632	Updated Sterile Procedural Kit	Biological & Environmental Control Laboratories			1986-09-29
K863588	Amylase Procedure	Data Medical Associates, Inc.	JFJ	Class II	1986-09-29
K863570	Le Veen Wound Splint	Tek-Aid, Inc.	KGS	Class I	1986-09-29
K863562	Uresil 150Cc Bellows Reservoir	Uresil, LLC	GCY	Class I	1986-09-29
K863560	Uresil Std Flat/round & Flat/round Split. Sili/dra	Uresil, LLC	GBS	Class I	1986-09-29
K863544	Easy-Test Carbon Dioxide (CO2) Item #67649/95	Em Diagnostic Systems, Inc.	KHS	Class II	1986-09-29
K863528	Bicondylar Toe Prosthesis	Depuy, Inc.			1986-09-29
K863489	Paramax Electrolyte Calibrator	American Dade	JIX	Class II	1986-09-29
K863486	Potassium Test	Sclavo, Inc.	CEJ	Class II	1986-09-29
K863447	Stryker Orthopower 90 & Orthopower 90 System II	Stryker Corp.	GET	Class I	1986-09-29
K863438	Nova II Sodium/potassium/lithium Analyzer	Nova Biomedical Corporation	JJP	Class I	1986-09-29
K863419	Emds(tm) Alcohol Testpacks, #67691/95	Em Diagnostic Systems, Inc.	DML	Class II	1986-09-29
K863409	Kundin Wound Gauge	Jane I. Kundin	FTY	Class I	1986-09-29
K863403	Phenytoin, as Performed on Technicon Ra Systems	Technicon Instruments Corp.	DIP	Class II	1986-09-29
K863388	Quantimetrix Drug Free Serum Control	Quantimetrix Corp.	DIF	Class I	1986-09-29
K863359	Bouffant-Style Surgical Cap	Kimberly-Clark Corporation	FYF	Class I	1986-09-29
K863337	Cordipak Cardiac Catheterization Pack	Angi-Pak Corp.	DQO	Class II	1986-09-29
K863333	Avl Ise-Trol Electrolyte Control	Avl Scientific Corp.	JJR	Class I	1986-09-29
K863332	Atac 4300 Hematology Cell Counter	Turpen Laboratory Systems, Inc.	GKL	Class II	1986-09-29
K863287	Uric Acid (Uricase) Method-II	Catachem, Inc.	JHC	Class I	1986-09-29
K863268	Alkaline Phosphatase Procedure	Data Medical Associates, Inc.	CJE	Class II	1986-09-29
K863258	Total Protein Procedure	Data Medical Associates, Inc.	CEK	Class II	1986-09-29
K863252	Cholesterol Procedure	Data Medical Associates, Inc.	CHH	Class I	1986-09-29
K863240	Prolactin Riabead II Diagnostic Kit	Abbott Medical	CFT	Class I	1986-09-29
K863198	Pregnaslide	Armkel, LLC	JHJ	Class II	1986-09-29
K863045	Programmer Model 2035/Electrogram Cable Model 6580	Cardiac Pacemakers, Inc.	KRG	Class III	1986-09-29
K863019	F-11 Reflector / F-II Standard Reflector	Sds Dental, Inc.	EAZ	Class I	1986-09-29
K862920	Bard William Harvey Cardiotomy Reservoir	C.R. Bard Inc	DTN	Class II	1986-09-29
K862840	Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N	Gambro, Inc.	FJG	Class II	1986-09-29
K862805	Angiomed Vac-U-Cut Biopsy Needle	Angiomed U.S., Inc.	GDM	Class I	1986-09-29
K862743	Pathfinder(tm) Respiratory Syncytial Virus	Kallestad Laboratories, Inc.	GQG	Class I	1986-09-29
K862733	Amylase Sr Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	JFJ	Class II	1986-09-29
K862354	Monofluor Chlamydia Trachomatis Dir Spec Test Kit	Synbiotics Corp.	LJP	Class I	1986-09-29
K862148	Olympus Au 5000 Flame Photometer Module	Olympus Corp.	JJO	Class I	1986-09-29
K862047	Coagulator (8 Channel)	Med USA	KQG	Class II	1986-09-29
K861641	Heparin-Coated Extracorporeal Circuits	American Bentley	DTZ	Class II	1986-09-29
K861244	Hdl/cholesterol Test System	Chrometrics Laboratories, Inc.	LBS	Class I	1986-09-29
K863707	Lovesafe Contraceptive Condoms, Type Sc-40	Manexim Multicorp, Ltd.	HIS	Class II	1986-09-26
K863706	Lovesafe Contraceptive Condoms, Type Nl-50	Manexim Multicorp, Ltd.	HIS	Class II	1986-09-26
K863650	Quantimap III	Quantified Signal Imaging, Inc.	OLT	Class II	1986-09-26
K863620	Raichem(tm) Chloride Reagent	Reagents Applications, Inc.	CHJ	Class II	1986-09-26
K863477	Emds(tm) Lactic Dehydrogenase Testpacks, #67660/95	Em Diagnostic Systems, Inc.	CFJ	Class II	1986-09-26
K863422	Delfia(tm) Cortisol Kit	Lkb Instruments, Inc.	JFT	Class II	1986-09-26