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 2026-10-21, 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 3017 of 3529

510(k) clearances, page 3017 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844857	Pacesetter Systems, Inc. Endocardial Screw-in Lead	Pacesetter Systems	DTD	Class II	1985-02-14
K844641	Fresenius Haemodialysis ;Machine A1008	Seratronics, Inc.	FKQ	Class II	1985-02-14
K844616	Siegen Visual Stimulator	Siegen Corp.	GWE	Class II	1985-02-14
K844469	Pharmacia B2-Micro Eia	Pharmacia, Inc.	JZG	Class II	1985-02-14
K844409	Dtl Electrode	Sauquoit Industries, Inc.	HLZ	Class II	1985-02-14
K844384	Biliary Stent Prosthesis	Mentor	FGE	Class II	1985-02-14
K843944	Ptca Balloon Catheters & Accessories	Advanced Cardiovascular Systems, Inc.	LOX	Class II	1985-02-14
K843939	Pediatric Size K-Tube a or B	Midwest Metabolic Support Group	KNT	Class II	1985-02-14
K843888	Cardiotomy Reservoir Brs-Xxx Series &	Gish Biomedical, Inc.	DTN	Class II	1985-02-14
K843851	Bodyscreen II	Erich Jaeger, Inc.	CCM	Class II	1985-02-14
K843846	Universal-Bodytest	Erich Jaeger, Inc.	CCM	Class II	1985-02-14
K843595	Cardiotomy Reservoir W/filter	Omnis Surgical, Inc.	DTN	Class II	1985-02-14
K843567	Kangaroo Nasogastric Feeding Tube	Chesebrough-Pond'S U.S.A. Co.	KNT	Class II	1985-02-14
K843319	Cilco I/a Surgical Pack	Cilco, Inc.	HQC	Class II	1985-02-14
K842318	Yki-770 Electronic Sphygmomameter	Yukosha Co., Inc.	DXN	Class II	1985-02-14
K844804	Lifesound - Electronic Stethoscope	Biomedical Concepts, Inc.	DQD	Class II	1985-02-13
K844665	Computer	Burdick Corp.	DXG	Class II	1985-02-13
K844293	Auto Dii Multi Frequency	Technicare Corp.	IYN	Class II	1985-02-13
K843933	Vingmed Ds100 Doppler Flowmeter	Vingmed, Inc.	JAF	Class II	1985-02-13
K843445	Sacral Bar	Stuart	KWP	Class II	1985-02-13
K842493	Agee External Fixator	The Hand Biomechanics Research Laboratory	JEC	Class II	1985-02-13
K842407	Pulsed Doppler Option, Continu-Wave	General Electric Co.	IYN	Class II	1985-02-13
K842388	Copal Digital Sphygmomanometer Ua-510	Takeda Medical, Inc.	DXN	Class II	1985-02-13
K850319	Y-Glutamyltransferase(y-Gt) Reagent	Sigma Diagnostics, Inc.	JQB	Class I	1985-02-12
K850146	Siredoc, Paper Chart Recorder	Siemens Medical Solutions USA, Inc.	DSF	Class I	1985-02-12
K844914	Abbott Pregna-Plus Human Chorionic Gonadotropin En	Abbott Medical	JHJ	Class II	1985-02-12
K844740	Models 43100A, 43110A & 43120A Defibrillator/monit	Hewlett-Packard Co.	LDD	Class II	1985-02-12
K844656	Ohmeda Double Swivel Adapter	GE Healthcare	BZA	Class I	1985-02-12
K844564	Argyle Laser Resistant Tracheal Tube W/murphy Eye	Sherwood Medical Co.	BTR	Class II	1985-02-12
K844359	Mobilization & Traction Table	Chattanooga Group, Inc.	ING	Class II	1985-02-12
K844240	Enzygnost Lipase Test	Behring Diagnostics, Inc.	CET	Class I	1985-02-12
K844028	Lord Screw Ring Acetabular Component	Howmedica Corp.	JDI	Class II	1985-02-12
K842474	Glucochek III	Larken Industries, Inc.	JJQ	Class I	1985-02-12
K842166	Intermed, Ins Sterile Water/saline	Intermed, Inc.	BSY	Class I	1985-02-12
K843549	Probeye Thermal Video Systems	Hughes Aircraft Co.	LHQ	Class I	1985-02-11
K850193	Pors-on HF-Solder(porcelain Dental Alloys)	Degussa Dental, Inc.	EJS	Class II	1985-02-08
K850113	C/pes 9103, ECG Stress Testing System	Gould, Inc.	DRT	Class II	1985-02-08
K850103	Gdc-1489 a Casting Alloy	Deringer-Ney, Inc.	EJS	Class II	1985-02-08
K850102	Gdc-1433 a Casting Alloy	Deringer-Ney, Inc.	EJS	Class II	1985-02-08
K850101	Gdc-1629 a Casting Alloy	Deringer-Ney, Inc.	EJS	Class II	1985-02-08
K850073	J & J Light Curing Dentin/enamel Bonding Agent	Johnson & Johnson Professionals, Inc.	EBD	Class II	1985-02-08
K850043	Cardioguard Stress Test Monitor 4002	Del Mar Avionics	DRT	Class II	1985-02-08
K850036	Coltene Precise	Coltene, Inc.	ELW	Class II	1985-02-08
K850021	Electrocardiograph-ECG Caliper	Devcom, Inc.	DPS	Class II	1985-02-08
K844966	Cardiobeeper Profile Monitor	Survival Technology, Inc.	DXH	Class II	1985-02-08
K844958	Medtronic Models 8432/8433/8434 - Pacemaker Pulse	Medtronic, Inc.	DXY	Class III	1985-02-08
K844957	Medtronic Model 8436 -Pacemaker Pulse Generator	Medtronic, Inc.	DXY	Class III	1985-02-08
K844872	Century Scale	Century Manufacturing Co.	FNG	Class II	1985-02-08
K844871	Century Saf-Lift Scale	Century Manufacturing Co.	FNG	Class II	1985-02-08
K844793	Suprima 253-21 Implantable Pulse Generator	Intermedics, Inc.	DXY	Class III	1985-02-08