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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3212 of 3528

510(k) clearances, page 3212 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821908	Starkey Model Hal-1	Starkey Laboratories, Inc.	ETW	Class II	1982-08-03
K821890	Critikon #817 Esophageal Multi-Probe	Critikon Company, LLC	BZT	Class II	1982-08-03
K820620	Biobrane R II Brand	Woodroof Mfg., Inc.	FRO	Unclassified	1982-08-03
K821792	Neumovent 980	Ultramar Marketing Corp.	CBK	Class II	1982-08-02
K822157	Peripheral Nerve Stimulator, Model a-200	P.B. Services	BXN	Class II	1982-07-30
K822143	Tomac Lubricating Jelly	American Medical Systems, Inc.	KMJ	Class I	1982-07-30
K822138	Neurostim II	Neuro Technology	BXN	Class II	1982-07-30
K822137	Digistim II	Beuro Technology	BXN	Class II	1982-07-30
K822135	Seca Digital Baby Scale 727	Seca Corp.	FRW	Class I	1982-07-30
K822109	Shovel Retractor	Bio-Blitz, Inc.	NBH	Class I	1982-07-30
K822097	D645-Bacteriological Gas Line Filter	Electromedics, Inc.	KRI	Class I	1982-07-30
K822046	Seralyzer Hemoglobin Calibrators	Miles Laboratories, Inc.	KRZ	Class II	1982-07-30
K822045	Seralyzer Hemoglobin Test Module	Miles Laboratories, Inc.	KHG	Class II	1982-07-30
K822044	Seralyzer Hemoglobin Reagent Strips	Miles Laboratories, Inc.	KHG	Class II	1982-07-30
K822015	Binocular Operating Microscopes and	Kelleher Corp.	FSO	Class I	1982-07-30
K822012	Binocular Operating Microscopes &	Kelleher Corp.	HBN	Class I	1982-07-30
K822009	Binocular Operating Microscopes &	Kelleher Corp.	EPT	Class I	1982-07-30
K821998	Respicord	Novamed Products, Inc.	BWF	Class II	1982-07-30
K821996	Leonard Peripheral Venous Pressure Cath	Norton Performance Plastics Corp.	DYG	Class II	1982-07-30
K821962	Bbl Staphyslide Test	BD Becton Dickinson Vacutainer Systems Preanalytic	JWX	Class I	1982-07-30
K821960	Bbl Pneumoslide Test	BD Becton Dickinson Vacutainer Systems Preanalytic	GWC	Class I	1982-07-30
K821956	Haem-C Plus Blood Reference Controls	Baker Instructions Corp.	JCN	Class II	1982-07-30
K821927	Table, Surg. Instrument & Dressing	Emerson-Sack-Warner Corp.			1982-07-30
K821921	Stand, Surg. Instrument & Dressing	Emerson-Sack-Warner Corp.	FSH	Class I	1982-07-30
K821888	Automatic Single Channel ECG #399	Birtcher Corp.	DPS	Class II	1982-07-30
K821846	Lds Monitoring Electrode	Life Design Systems, Inc.	DRX	Class II	1982-07-30
K821836	Pregnancy (W) Edge	Body Therapeutics, Inc.	QSB	Class I	1982-07-30
K821829	Urogard	Buckman Consultants	KNX	Class II	1982-07-30
K821802	Centurion Electrode Belt	Clinical Data, Inc.	DRX	Class II	1982-07-30
K821762	Measelisa Test Kit	M.A. Bioproducts	LJB	Class I	1982-07-30
K821445	Argyle Ferguson Left Atrial Vent Cath	Sherwood Medical Co.	DWF	Class II	1982-07-30
K821434	EKG (ECG) Electrodes	Dupaco, Inc.	DRX	Class II	1982-07-30
K821249	Eni Antibody to Measles(rubeola) Virus	Electro-Nucleonics Laboratories, Inc.	GRE	Class I	1982-07-30
K821013	Ivex-Hp Pediatric Extension Set-Sl	Abbott Medical	FPB	Class II	1982-07-30
K820672	Hasson Buec-3	Bivona Medical Technologies	HDP	Class II	1982-07-30
K822047	Intersorb Dry Burn Vest & Pants	Chesebrough-Pond'S U.S.A. Co.	NAB	Class I	1982-07-28
K822043	Seca Chair Scale-721	Seca Corp.	FRW	Class I	1982-07-28
K822042	Seca Light Weight Baby Scale 744	Seca Corp.	FRW	Class I	1982-07-28
K822029	Monojet 520 20Cc Syringes W/needles	Sherwood Medical Co.	FMF	Class II	1982-07-28
K822023	Deseret Subclavian Jugular Cath. Set	Warner-Lambert Co.	FOZ	Class II	1982-07-28
K822013	Nagashima Sn Automatic Treatment Chair	Kelleher Corp.	GBB	Class I	1982-07-28
K822005	Specimen Collectors	Kelleher Corp.	GCX	Class II	1982-07-28
K821957	Cath-Lok	Hpd Medical, Inc.	KMK	Class I	1982-07-28
K821940	The Humphrey Field Analyzer Model 610	Zeiss Humphrey System	HPT	Class I	1982-07-28
K821896	C-300 Infant Incubator	Narco Scientific	FMZ	Class II	1982-07-28
K821887	Scanlan Suture-Statt	Scanlan Intl., Inc.	HRQ	Class I	1982-07-28
K821886	Deseret Insyte Hyperthermia Catheter	Warner-Lambert Co.	FLL	Class II	1982-07-28
K821850	Galtel-18	Galvanic Medical Instruments, Inc.			1982-07-28
K821842	Gas Sterilization Equipment	Getinge International, Inc.	FLF	Class II	1982-07-28
K821801	Norsen Debrider	Bel-Med, Inc	GED	Class I	1982-07-28