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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2795 of 3530

510(k) clearances, page 2795 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872455	Dps-4100 Plus Digital Radiography System	Philips North America LLC	LLZ	Class II	1987-09-01
K872202	Adjustable PEEP Valve	Med Air Technology, Inc.	BYE	Class II	1987-09-01
K872167	Cardiotomy/mediastinal Auto. Reservoir Catr-3500	American Bentley	DTP	Class II	1987-09-01
K872085	The Gamma-B Anti-Ds DNA Kit & Optional Controls	Immunodiagnostics, Ltd.	LSW	Class II	1987-09-01
K871389	Holter St System, Model No. 5000-20	Holter Data Services	DSI	Class II	1987-09-01
K871349	Howmedica Kinematic II Modular Tibial Component	Howmedica Corp.	JWH	Class II	1987-09-01
K871048	Micro Mammo I Mammography Unit	Amerasia Import-Export, Inc.	IZH	Class II	1987-09-01
K870804	Cardioplegia Heat Exchanger Model No. He-100	American Bentley	DTR	Class II	1987-09-01
K873117	Biotrol Glucose Enzymatique Color Reagent	Biotrol, USA, Inc.	CGA	Class II	1987-08-31
K863270	Gene-Trak Campylobacter Assay	Integrated Genetics	LQO	Class I	1987-08-31
K873109	Model Cc-72 Cavernosometry/cavernosography Set	Life-Tech Intl., Inc.	OJA	Class II	1987-08-28
K873103	Technicon H*1 Jr.(tm) System	Technicon Instruments Corp.	GKL	Class II	1987-08-28
K873049	Triglycerides Gpo without Free Glycerol	Boehringer Mannheim Corp.	CDT	Class I	1987-08-28
K872968	Ultrascan Ige Assay Kit	Specialty Medical Industries, Inc.	DGC	Class II	1987-08-28
K872583	Cedia Digoxin Cr Assay	Microgenics Corporation	KXT	Class II	1987-08-28
K872321	Emds Salicylate (Sal) Calibrator, No# 67641/93	Em Diagnostic Systems, Inc.	DKJ	Class II	1987-08-28
K872310	Curad Medicated Plastic Strips	The Kendal Co.	CGX	Class II	1987-08-28
K872107	William Harvey Hf5000 Membrane Oxygenator	Medivators Inc	DTZ	Class II	1987-08-28
K871856	Annular Array Scanhead	Advanced Technology Laboratories, Inc.	HGL	Class II	1987-08-28
K871129	Cavropump	Life-Tech Intl., Inc.	DXT	Class II	1987-08-28
K864849	Antek 703C Chemiluminescent Nitrogen Analyzer	Antek Instruments, Inc.	JJE	Class I	1987-08-28
K864223	Iq Digoxin	BD Becton Dickinson Vacutainer Systems Preanalytic	KXT	Class II	1987-08-28
K873167	Kodak Min-R Medium Screen	Eastman Kodak Company	EAM	Class I	1987-08-27
K872980	Mam-Cp X-Ray Apparatus	Transworld X-Ray Corp.	IZH	Class II	1987-08-27
K872537	Prothrombin Time Test	Sclavo, Inc.	GJS	Class II	1987-08-27
K872454	Biomet Modular Shoulder Prosthesis	Zimmer GmbH	KWT	Class II	1987-08-27
K872114	Bactigen Group B Streptococcus-Cs Test	Armkel, LLC	GTZ	Class I	1987-08-27
K872077	Model 1858 Cavro/pressure Module	Life-Tech Intl., Inc.	EXY	Class II	1987-08-27
K871110	Coronary Artery Bypass Graft (Cabg) Marker	Edward Weck, Inc.	DSY	Class II	1987-08-27
K873046	Ovonic Coated Surgical Scissors	Micrins, Ltd.	LRW	Class I	1987-08-26
K872785	Biotrol-33 Plus Assayed Chemistry Control Serum	Biotrol, USA, Inc.	JJY	Class I	1987-08-26
K872777	Biotrol-33 Plus Pathologique Assayed Chem. Control	Biotrol, USA, Inc.	JJY	Class I	1987-08-26
K872647	International Model at 8185 Custom-in-the-Ear	Int'L Hearing Aids, Inc.	ESD	Class I	1987-08-26
K872535	Biopro Femoral Hip Component	Biopro, Inc.	KWL	Class II	1987-08-26
K872296	Bile Acids Reagent	Sigma Diagnostics, Inc.	KWW	Class II	1987-08-26
K872147	Kerr Cavalite	Kerr Corporation (Danbury)	EJK	Class II	1987-08-26
K872141	Centurion Specimen Trap W/catheter	Centurion Medical Products, LP	BSY	Class I	1987-08-26
K871846	Flexiflo Toptainer Top-Fill Enteral Nutrit. System	Abbott Medical	KNT	Class II	1987-08-26
K871601	Advance* Pregnancy Test Acp 2 Pregnancy Test	Advanced Care Products	LCX	Class II	1987-08-26
K871557	Discipline II Rtd	Physio Systems, Inc.	IKK	Class II	1987-08-26
K871536	Ophthasonic a-Scan/ B-Scan	Teknar, Inc.	IYO	Class II	1987-08-26
K873209	Plaque-Sweep	Dentsply Intl.	EFB	Class I	1987-08-25
K873208	Manan Turner Style Needle	Manan Manufacturing Co., Inc.	KNW	Class II	1987-08-25
K873120	Abbott a-Gent Iron Reagent Kit	Abbott Medical	CFM	Class I	1987-08-25
K873095	(Mem) Eagle No. M3149 W/hanks' Salts	Sigma Chemical Co.	KIT	Class I	1987-08-25
K873094	(Mem) Eagle No. M7399 W/earle's Salts	Sigma Chemical Co.	KIT	Class I	1987-08-25
K873093	(Mem) Eagle No. M3024 W/earle's Salts	Sigma Chemical Co.	KIT	Class I	1987-08-25
K873092	Rpmi-1640 Medium No. R7755 Auto-Mod(tm) W.o/l-Glu.	Sigma Chemical Co.	KIT	Class I	1987-08-25
K873091	Ames' Medium No. A1420 W/l-Gluta. W.o/sod. Bicarb.	Sigma Chemical Co.	KIT	Class I	1987-08-25
K873090	Medium 199 No. M3274 W/hanks' Salts W.o/l-Glutami.	Sigma Chemical Co.	KIT	Class I	1987-08-25