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 2026-10-22, 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 2845 of 3529

510(k) clearances, page 2845 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864173	Hpd Humidifying Chamber	Hpd Medical, Inc.	BTT	Class II	1987-01-30
K870047	Coltene Rapid	Coltene, Inc.	ELW	Class II	1987-01-29
K864345	Nte-2 Thermal Sensitivity Tester	Sensortek, Inc.	LQW	Class I	1987-01-29
K863985	Evoport 100	JEDMED Instrument Company	GWJ	Class II	1987-01-29
K850100	Blood Lancet	Gainor Medical	FMK	Class II	1987-01-29
K870100	Plaster Stand	Mizuho Orthopedic Systems Inc	LGG	Class I	1987-01-28
K870084	Rd 140 Surgical Bender	Terray Manufacturing, Inc.	HXW	Class I	1987-01-28
K870043	Guo Guang Wheel Chair	China National Medicines & Health Prod. I/E Corp.	IOR	Class I	1987-01-28
K864935	'Exmoor' Shah Packing Strips	Exmoor Plastics Limited			1987-01-28
K864934	'Exmoor' Shah Silicone Discs	Exmoor Plastics Limited	EPP	Class I	1987-01-28
K864929	Hall (R) Micro E Powered Surgical Instrument Syst	Hall Surgical, Division of Zimmer, Inc.	HWE	Class I	1987-01-28
K864902	Mod. 4003 Adu., Oxy. Delive.-Oral/nasal CO2 Cannu.	Salter Labs	CCK	Class II	1987-01-28
K864883	Neonatal Cannula Cap	Behan & Taylor Ent.	BZD	Class II	1987-01-28
K864750	Kotex Security Tampons, Regular and Super	Kimberly-Clark Corporation	HEB	Class II	1987-01-28
K864641	Ventex-Ia	Ventech Corp.	IKN	Class II	1987-01-28
K864487	Lifewatch Sensor Belt	Lifewatch Systems, Inc.	BZQ	Class II	1987-01-28
K864280	Econol (Portable) Econo 30 & 40 Liter Base Unit	Smith-Taylor Mfg. Co., Div. Allied Medical Corp.	BYJ	Class II	1987-01-28
K864103	Curity Anesthesia Filter	The Kendal Co.	CAH	Class II	1987-01-28
K864085	Brooker Bio-Groove Femoral Component	Zimmer GmbH	KWL	Class II	1987-01-28
K864005	Alpine	Mountain Medical Equipment, Inc.	CAW	Class II	1987-01-28
K863866	Respiradyne Ii(tm)	Chesebrough-Pond'S U.S.A. Co.	BZK	Class II	1987-01-28
K864498	O.b.(tm) Tampon	Personal Products Co.	HIL	Class II	1987-01-27
K864447	Narkomed 2B Anesthesia System	Draeger, Inc.	BSZ	Class II	1987-01-27
K864136	260Sl Imaging System Small Parts Probes	GE Medical Systems Information Technologies, Inc.	ITX	Class II	1987-01-27
K864135	280Sl Imaging System Small Parts Probes	GE Medical Systems Information Technologies, Inc.	ITX	Class II	1987-01-27
K864070	Whiteside Ortholoc (Tm)	Dow Corning Wright	HRY	Class II	1987-01-27
K863711	Regulator Oxygen Mechanical	Lifeguard Medical Products, Inc.	CAN	Class I	1987-01-27
K861069	Teca Neuropto with Os-5 Stimulator	Teca, Inc.	GWE	Class II	1987-01-27
K862755	Dunn Anterior Distraction System	Osteotek, Inc.			1987-01-22
K870103	Lead Apron Caddy	Mizuho Orthopedic Systems Inc	EAJ	Class I	1987-01-21
K870071	Toshiba, Smit Roentgen	North American Imaging, Inc.	ITY	Class I	1987-01-21
K870044	Mcd Specialty Brand Needle Counters	Medical Concepts Development, Inc.			1987-01-21
K870033	Amresco Flow Pac Potassium Reagent Set, #1460	American Research Products Co.	CEM	Class II	1987-01-21
K870017	Amg + Med Lancet	Can-Am Surgical Corp.	FMK	Class II	1987-01-21
K865072	Arrow Xt Powered Wheelchair	Ivacare Corp.	ITI	Class II	1987-01-21
K864953	Weighmobile, in Bed Patient Weighing Scale	Dittmar and Penn Corp.	FRW	Class I	1987-01-21
K864882	Ferrozine (Colorimetric) Iron Binding Capacity	Horiba Instruments Incorporated	JIY	Class I	1987-01-21
K864879	Osi Papoose Board	Mizuho Orthopedic Systems Inc			1987-01-21
K864827	Rsvp Systems, Series I, Bed-Patient Monitor	Tactilitics, Inc.	KMI	Class I	1987-01-21
K864808	Strato(r) Pca Infuser	Strato Medical Corp.	FRN	Class II	1987-01-21
K864725	Modi. Dicor Castable Ceramic/all Porcelain Bridges	Dentsply Intl.	EMA	Class II	1987-01-21
K864673	Unscented Menstrual Pad	Procter & Gamble Mfg. Co.	HHL	Class II	1987-01-21
K864667	Penox Hospital Bed	Penox Technologies, Inc.	FNJ	Class I	1987-01-21
K864581	Applidyn	Grandcor Medical Systems	ISD	Class II	1987-01-21
K864541	Bt Hypodermic Syringe	Baron Technologies, Inc.	FMF	Class II	1987-01-21
K864480	Il Test 84668-15, Factor VIII Control Plasma	Instrumentation Laboratory Co.	GGP	Class II	1987-01-21
K864464	Psi Amylase Reagent	Horiba Instruments Incorporated	JFJ	Class II	1987-01-21
K864439	Beckman Epsilon(tm) Prolactin Test Kit	Beckman Instruments, Inc.	CFT	Class I	1987-01-21
K864356	Amylase Reagent	Trace Scientific, Ltd.	CIJ	Class II	1987-01-21
K863709	Challenge Orthodontic Bonding Adhesive	Ormco Corp.	DYH	Class II	1987-01-21