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 2026-10-19, 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 3030 of 3529

510(k) clearances, page 3030 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844281	Ptk Healthcheck Pregnancy Test Kit	Healthcheck Corp.	LCX	Class II	1984-12-10
K844171	Phenytoin Radioimmunoassay Using the Aria Ht Syste	BD Becton Dickinson Vacutainer Systems Preanalytic	LGR	Class II	1984-12-10
K844164	Reactifs, Ibf Ultrogels Aca & Ultrogels a	Lkb Instruments, Inc.	DII	Class I	1984-12-10
K844021	Ise Reagents for Demand Analyzer	Advanced Biomedical Methods, Inc.	CGZ	Class II	1984-12-10
K843796	Sterile Water	Paco Pharmaceutical Services, Inc.			1984-12-10
K842880	Mechanical Sector Probe 4 Mhz Dfm	General Electric Co.	IYO	Class II	1984-12-10
K844174	Flexible Stainless Steel Stylet for Enternal Feedi	Exco, Inc.	KNT	Class II	1984-12-07
K844124	Toshiba Digital Clinical Thermometer	Toshiba Medical Systems	FLL	Class II	1984-12-07
K843887	IV Jet	Nuclear Concepts, Inc.	FMF	Class II	1984-12-07
K843519	Minuteman CO2 Microsurg Laser Gen Surg	American Surgical Laser, Inc.	GEY	Class I	1984-12-07
K843518	Minuteman C02 Microsurg Laser Podiatry	American Surgical Laser, Inc.	GEY	Class I	1984-12-07
K843517	Minuteman CO2 Microsurg Laser Dermatol-	American Surgical Laser, Inc.	GEY	Class I	1984-12-07
K843415	Top Hypodermic Syringe Luer Lock	Top Surgical Manufacturers Co.	FMF	Class II	1984-12-07
K842959	Mc-4000 Console & Probes	Cryomedics LLC	GEH	Class II	1984-12-07
K842946	Acu-Patch	Acutek	KGX	Class I	1984-12-07
K842370	Page-Writer Interpretive Cardiograph	Hewlett-Packard Co.	DXH	Class II	1984-12-07
K842174	Percutaneous Gastrostomy Tube	Mount Carmel Mercy Hospital	KNT	Class II	1984-12-07
K841604	Adjust-a-Temp High Temperature	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-12-07
K841603	Adjust-a-Temp Micro	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-12-07
K841509	Replace-a-Tip Adjustable High Temp.	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-12-07
K841459	Replace-a-Tip Adjust. Low Temp.-	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-12-07
K844141	Entamoeba Histolytica Hk-9 Antigen (Axenic)	Lmd Laboratories	KHW	Class II	1984-12-06
K844105	Fitc Labeled Chlamydiae Monoclonal Antibody	Bartels Immunodiagnostic Supplies, Inc.			1984-12-06
K843900	Focuscope Universal System	Medical Diagnostics, Ca.	GDB	Class II	1984-12-06
K843878	Heparin Infusin Pump	Armament Systems, Inc.	FRN	Class II	1984-12-06
K843773	Cadd-Pac 5200 Ambulatory Infusion Pump	Deltec Systems, Inc.	FRN	Class II	1984-12-06
K843772	Cadd-1 5100 Ambulatory Infusion Pump	Deltec Systems, Inc.	FRN	Class II	1984-12-06
K843566	Ketac-Silver	Espe GmbH (US)	EMA	Class II	1984-12-06
K843130	Scanhead 2.25Mhz Added to Ultramark 4	Advanced Technology Laboratories, Inc.	JOP	Class II	1984-12-06
K843129	Scanhead 2.25Mhz Added to Ultramark 8	Advanced Technology Laboratories, Inc.	JOP	Class II	1984-12-06
K844570	Quantum 412	Keta Corp.	HPT	Class I	1984-12-05
K844465	Pms Drape Pack	Professional Medical Services	KKX	Class II	1984-12-05
K844363	Ophthalmic Stand	Luneau Laboratories	HMF	Class I	1984-12-05
K844222	Biosearch Glaser Peg Percutaneous Endoscopic Gastr	Biosearch Medical Products, Inc.	KNT	Class II	1984-12-05
K844090	Percutaneous Nephrostomy Trocar Sys	American Edwards Laboratories	LJE	Unclassified	1984-12-05
K843813	Intravenous Start Kit	Pro-Lab, Inc.			1984-12-05
K843478	Pharma-Plast Uridrop-Uridome	Zimmar Consulting, Ltd.	KNX	Class II	1984-12-05
K843477	Pharma-Plast Rectal Tip	Zimmar Consulting, Ltd.	FCF	Class II	1984-12-05
K843352	Coloscreen Self-Test	Helena Laboratories, Corp.	KHE	Class II	1984-12-05
K843303	Coulter Counter Model M4	Coulter Electronics, Inc.	GKL	Class II	1984-12-05
K844494	Medipart Face Mask Mp-Xm	Medipart Jerry Alexander	BSJ	Class I	1984-12-04
K844493	Medipart Face Mask & Filter Mp-30Xm	Medipart Jerry Alexander	BSJ	Class I	1984-12-04
K844492	Medipart Bacteria Filter Mp-30X	Medipart Jerry Alexander	CAH	Class II	1984-12-04
K844491	Medipart Filter & Tubing Mp-02X	Medipart Jerry Alexander	CAH	Class II	1984-12-04
K844348	Dynascope Monitor Ds-800	Fukuda Denshi USA, Inc.	DRT	Class II	1984-12-04
K844328	Oxygen Concentrator	Hospitak, Inc.	CAW	Class II	1984-12-04
K844296	Tracheal Tube, Reinforced, Cuffed	Sheridan Catheter Corp.	BTR	Class II	1984-12-04
K844196	Wet Skin Scrub Tray Sterile Wet Skin Scrub Kit	Biological & Environmental Control Laboratories	KME	Class I	1984-12-04
K843889	Respironics Sleepeasy Nasal CPAP Sys	Respironics, Inc.	BYE	Class II	1984-12-04
K843843	He Test	Erich Jaeger, Inc.	BSE	Class II	1984-12-04