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 3405 of 3526

510(k) clearances, page 3405 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790995	Contex	Foam Tek, Inc.	FMP	Class I	1979-06-11
K790988	Model 6971 W/ Dbs Wire	Medtronic, Inc.	DTB	Class III	1979-06-11
K790968	Catheter Metal Hub/nonradiopaque	Jelco Laboratories	FOZ	Class II	1979-06-11
K790966	Ultrasonic Humidifier	Hankscraft Div. of Gerber Products Co.	KFZ	Class I	1979-06-11
K790939	Model 78501A Patient Monitoring System	Hewlett-Packard Co.	DPS	Class II	1979-06-11
K790882	Lead Introducer Set	Introstat	DQX	Class II	1979-06-11
K790838	Arterial Embolectomy Catheter (Modified)	Shiley, Inc.	DXE	Class II	1979-06-11
K790756	Heat Exchanger Coil	Delta Medical Industries	DTR	Class II	1979-06-11
K790565	Aortic Root Cannula	Dlp, Inc.	DWF	Class II	1979-06-11
K790504	Sandee Sanding Block	Dr. Bertram L. Steel	LDQ		1979-06-11
K790444	Elecath Multi-Purpose Arterial Surger	Electro-Catheter Corp.	GBA	Class I	1979-06-11
K790535	Clayton Colon Cleansing Kit	Clayton Medical Products, Inc.	FCE	Class I	1979-06-07
K790805	Drug Abuse Dipsticks	Technical Resources, Inc.	DIT	Class II	1979-06-06
K790545	Stress Testing System, Lateral Tilting	Engineering Dynamics Corp.	DRT	Class II	1979-06-06
K790990	Reynolds Double Hemoclip Appliers	Edward Weck, Inc.	GDO	Class I	1979-06-05
K790972	Kimlon Impervious Stockinettes	Kimberly-Clark Corporation	KKX	Class II	1979-06-05
K790952	Clamp Covers	Medi-Spec	GAD	Class I	1979-06-05
K790946	Gordon Ivs Intravenous Stabilizer	Whitman Medical Corp.	GBJ	Class I	1979-06-05
K790896	Two-Way Anesthesia Filter	Pharmaseal Div., Baxter Healthcare Corp.	CAH	Class II	1979-06-05
K790887	Tee Adapter	Airlife, Inc.	BZA	Class I	1979-06-05
K790874	Amalcap-Non-Gamma-2	Vivadent (USA), Inc.	EJJ	Class II	1979-06-05
K790854	Forceps #101 and #102	C. Intl.	GEN	Class I	1979-06-05
K790818	Medi-Trace EEG Creme	Graphic Controls Corp.	GYB	Class II	1979-06-05
K790798	Fetal Maturity Test Procedure	Helena Laboratories, Corp.	JHG	Class II	1979-06-05
K790544	Stress Testing System, Multi-Position	Engineering Dynamics Corp.	DRT	Class II	1979-06-05
K782018	Leads, Implantable Cardiac Pacemakers	Oscor Inc.	DTB	Class III	1979-06-04
K791003	ECG Electrodes, Pediatric-Microporous Ta	Physio Control, Inc.	DRX	Class II	1979-06-01
K791002	ECG Electrodes, Pediatric-Foam Tape	Physio Control, Inc.	DRX	Class II	1979-06-01
K790945	Model 113 Treonic Ip3 Digital Syringe Pu	Vickers America Medical Corp.	FRN	Class II	1979-06-01
K790879	Ultipor Solution Container Filter	Pall Biomedical Products Co.	FPB	Class II	1979-06-01
K790761	Fetasonde Model 2108	Roche Medical Electronics, Inc.	HGM	Class II	1979-06-01
K790757	Lifepak 5 Monitor, Cassette, #800923-01	Physio Control, Inc.	DSH	Class II	1979-06-01
K790754	Browne Model Cf-1 and Cf-1G	Browne Corp.	FAP	Class II	1979-06-01
K790728	Touchless Tm Foley Catheter Kit	Diamed Division Ill. Tool Works, Inc.	KOD	Class II	1979-06-01
K790699	Tecnol Body Holder	Tecnol New Jersey Wound Care, Inc.	FMQ	Class I	1979-06-01
K790666	Vitalith S 3000 Series	Vitatron Medical BV	DXY	Class III	1979-06-01
K790559	Alarm	Maddak, Inc.	FRN	Class II	1979-06-01
K790548	Endocardial Pacing Lead, Model 476-01	Intermedics, Inc.	DTB	Class III	1979-06-01
K790478	Browne Model Ud-4De	Browne Corp.	FAP	Class II	1979-06-01
K790476	Quickscan Holter II	Intl. Medical, Inc.	DSH	Class II	1979-06-01
K790411	Auto Trauma Kit	Marshall Electronics, Inc.	KME	Class I	1979-06-01
K782113	Cap, Tamper Proof Plastic	Acacia, Inc.	KPE	Class II	1979-06-01
K790959	Lifepatch ECG Electrodes	Physio Control, Inc.	DRX	Class II	1979-05-31
K790903	Tracor Model Ra-411 Microprocessor	Tracor Instruments, Inc.	EWO	Class II	1979-05-31
K790867	Cardiac Pulse Generator, 16 Series	Telectronics, Inc.	DXY	Class III	1979-05-31
K790850	t.e.n.s.* Single-Use Electrode	3M Company	GXY	Class II	1979-05-31
K790843	Snap-Way	Northwest Orthodontics, Inc.	DZB	Class II	1979-05-31
K790826	Coagulation Arp	Helena Laboratories, Corp.	JPK	Class II	1979-05-31
K790825	Ls-8 Visicorder	Honeywell, Inc.	DSF	Class I	1979-05-31
K790799	Pulptester Model 2001	Analytic Technology	EAT	Class II	1979-05-31