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 3468 of 3526

510(k) clearances, page 3468 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K771393	Elhctronic Sphygmomanometer	C.R. Bard Inc	DXN	Class II	1977-11-11
K772053	Line Charger Model Lc-100	Datascope Corp.	DRT	Class II	1977-11-09
K772048	Single & Dual Channel Recorder	Hewlett-Packard Co.	DSF	Class I	1977-11-09
K772044	Techsight Lenses with Zuma Coating	Techsight Corp.	HQG	Class I	1977-11-09
K772027	Cardiocassette II	Cardiodyne, Inc.	DSH	Class II	1977-11-09
K772024	Rx Lens Series	Gentex Corporation	HQG	Class I	1977-11-09
K771976	ECG Amplifier/r Wave Trigger	G.D. Searle and Co.	DRR	Class II	1977-11-09
K771914	Subjective Refractor, Mosel Sr-111	American Optical Corp.	HKO	Class I	1977-11-09
K771900	71110 Desk Charger	Welch Allyn Inc	HLS	Class I	1977-11-09
K771881	Replica Bonding Agent	Hoyt Laboratories			1977-11-09
K771866	Troutman Corneal Punch	Edward Weck, Inc.	HRH	Class I	1977-11-09
K771776	ECG Cluster Electrode	C.R. Bard Inc	DRX	Class II	1977-11-09
K771669	Diag. Kit for Total Antithrombin III	Abbott Medical	JBQ	Class II	1977-11-09
K771512	Counter Model S Plus Blood Cell Counter	Coulter Electronics, Inc.	GKL	Class II	1977-11-09
K771394	Electronic Stethescope	C.R. Bard Inc	DXN	Class II	1977-11-09
K771488	P1 Blood Group Substance	Ortho Diagnostics, Inc.	KSX	Class II	1977-11-08
K771487	Lewis Blood Group Substance	Ortho Diagnostics, Inc.	KSX	Class II	1977-11-08
K772012	Video Adapter for Graphic Recorders	Honeywell, Inc.	IYO	Class II	1977-11-07
K771973	Gingitract	Den-Mat Corp.	EIG	Class I	1977-11-07
K771932	Recorder, Dinmap, Model 950	Applied Medical Research	DSH	Class II	1977-11-07
K771908	ISO-Shield Saliva Absorbers	3M Company	KHR	Class I	1977-11-07
K771821	Stac System	Technicon Instruments Corp.	JJF	Class I	1977-11-07
K771814	Reagent Confidence Sera	Ortho Diagnostics, Inc.	KSF	Class II	1977-11-07
K771728	Auto. Leucocyte Differ. Analyzer D/90	Technicon Instruments Corp.	GKL	Class II	1977-11-07
K771660	Kwick Kooler	World Trade Assoc.	IMD	Class I	1977-11-07
K771548	Silastic Brand Intravaginal Tarsette	Dow Corning Corp. Healthcare Industries Materials	HHW	Class II	1977-11-07
K771479	Nitrox 30 - Anesthetic Gas Proportioner	Ohio Medical Products	BSZ	Class II	1977-11-07
K772058	Lead Adaptor Kit Model 5866-21	Medtronic, Inc.	DTD	Class II	1977-11-03
K772057	Bipolar Pacemaker Model 224	Intermedics, Inc.	DXY	Class III	1977-11-03
K772026	Cardiac Pulse Generator, Model 150L	Telectronics, Inc.	DXY	Class III	1977-11-03
K772004	Human C4 Complement Control Serum	G.D. Searle and Co.	DBI	Class II	1977-11-03
K772003	Human Reference Serum C4 Complement	G.D. Searle and Co.	DAK	Class II	1977-11-03
K771991	Cardiac Output Thermodilution Module	Abbott Medical	DXG	Class II	1977-11-03
K771939	Stac System-Addi. Analytes	Technicon Instruments Corp.	JJF	Class I	1977-11-03
K771856	Dir. Quant. Color. Determ. Serum Creat.	Stanbio Laboratory	CGX	Class II	1977-11-03
K771849	Cpk Color Test Kit	Mallinckrodt Critical Care	CGS	Class II	1977-11-03
K771838	Serum Iron	Gamma Enterprises, Inc.	JIY	Class I	1977-11-03
K771834	Creatinine	Gamma Enterprises, Inc.	CGX	Class II	1977-11-03
K771720	Amido Black Concentrate	Sigma Chemical Co.	CEF	Class I	1977-11-03
K771380	Elapsed Time Indicator Model 21361A	Hewlett-Packard Co.	DPS	Class II	1977-11-03
K771153	Dyna Zyme II Got 340	J.T. Baker Chemical Co.	CIT	Class II	1977-11-03
K771152	Dynazyme II Gpt 340	J.T. Baker Chemical Co.	CKA	Class I	1977-11-03
K772021	Trc Stainless Steel Safety Spring Guides	Usci, Div. C.R. Bard, Inc.	DQX	Class II	1977-11-02
K772020	Cloth Adhesive Tape	Johnson & Johnson Professionals, Inc.	FPX	Class I	1977-11-02
K772014	Ames T-4 Strip Test	Miles Laboratories, Inc.	CDX	Class II	1977-11-02
K772002	Plates for Human C4 Complement	G.D. Searle and Co.	DBI	Class II	1977-11-02
K772001	Sarnes Help	3M Health Care, Sarns	DTQ	Class II	1977-11-02
K771994	Electrotherm Model Ht-1	Electromedics, Inc.	FLL	Class II	1977-11-02
K771993	Aft System	Calbiochem	DBM	Class II	1977-11-02
K771992	L-501 Cardiac Pacemaker	Coratomic, Inc.	DXY	Class III	1977-11-02