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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2091 of 3531

510(k) clearances, page 2091 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950714	Cook Insemination Cup	Cook Incorporated	HDR	Class II	1995-05-11
K950466	B-D Ultra-Fine II Pen Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1995-05-11
K950108	R-Med Mini-Retractor	R-Med, Inc.	HET	Class II	1995-05-11
K946359	Karl Storz Dilation Set, Reducers, Thread Sleeves, Distance Holders	Karl Storz Endoscopy-America, Inc.	HET	Class II	1995-05-11
K946320	R 302	Ralco S.r.l.	KPW	Class II	1995-05-11
K946298	Biostim-Hv	Progressive Concepts, Inc.	IPF	Class II	1995-05-11
K945803	Thermaflex, Model Sd 55 C.p.m.h.	Burke Neutech, Inc.	JFA	Class I	1995-05-11
K945753	Fst Fiberoptic Pressure Converter	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1995-05-11
K945489	Lyfo(tm) Differential Disk	Microbiologics, Inc.	JSP	Class I	1995-05-11
K945488	Lyfo(tm) Differential Disk	Microbiologics, Inc.	JSP	Class I	1995-05-11
K945487	Lyfo(tm) Differential Disk	Microbiologics, Inc.	JSP	Class I	1995-05-11
K945320	Tetrad Model Bg22, Automatic Biopsy Unit Model	Tetra Corp.	ITX	Class II	1995-05-11
K944590	Ethicon Drill Bit and Drill Guide	Ethicon, Inc	HSZ	Class I	1995-05-11
K944445	Ed Corp Radiation Screen	Med Corp.	EAK	Class I	1995-05-11
K944046	Fuji Computed Radiography Systems	FUJIFILM Healthcare Americas Corporation	IXW	Class II	1995-05-11
K943797	Babycare Neo2 Oxygen Concentration Controller	BPR Medical Limited	BZR	Class II	1995-05-11
K943727	Biostop G Bone Cement Restrictor	Landos, Inc.	LZN	Class II	1995-05-11
K943517	Staclot Heparin Test Kit	American Bioproducts Co.	KFF	Class II	1995-05-11
K943513	Ps II	Washington Biotechnology	LYR	Class I	1995-05-11
K942884	Coaguchek System	Boehringer Mannheim Corp.	GJS	Class II	1995-05-11
K941438	Op-Pneu Electronic CO2	Wisap/U.S.A.	HIF	Class II	1995-05-11
K941191	Real Time Stereotix	GE Healthcare	IZH	Class II	1995-05-11
K941127	Qct-Bone Mineral Analysis Software	Image Analysis, Inc.	KGI	Class II	1995-05-11
K940209	Ortho Assayed Reference Plasma-Normal/ Plasma-Abnormal	Ortho Diagnostic Systems, Inc.	GGN	Class II	1995-05-11
K936236	Shimadzu Image Amplifier Ia-12Lm Series	Shimadzu Medical Systems	JAA	Class II	1995-05-11
K935994	Pw Doppler Vascular Probes	Koven Technology, Inc.	ITX	Class II	1995-05-11
K935213	Incontrol	Thought Technology Ltd.	HIR	Class II	1995-05-11
K932149	Thought Technology Vaginal & Rectal Electrode	Thought Technology Ltd.	HIR	Class II	1995-05-11
K924312	Nurture III	Bailey Medical Engineering	HGX	Class II	1995-05-11
K952164	Emi Model Fff-Ia	New York Heart Instruments, Inc.	DQK	Class II	1995-05-10
K951917	Johnson & Johnson Easy Slide Dental Floss	Johnson & Johnson Consumer Products, Inc.	JES	Class I	1995-05-10
K951752	Active Igf-I Elisa	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1995-05-10
K951707	Dsl Active Ifgbp-3 Elisa	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1995-05-10
K951582	Ultradent Porcelain Etch	Ultradent Products Inc.	EIH	Class II	1995-05-10
K951502	Cvd Bullet Infusion Catyheter	Cardiovascular Dynamics, Inc.	KRA	Class II	1995-05-10
K951438	Benson and Ashley	Benson & Ashley, Inc.	HQY	Class I	1995-05-10
K951417	Carrasyn Hydrogel Wound Dressing, Fdg Pads, Carragauze Pads, Strips	Carrington Laboratories, Inc.	MGQ	Unclassified	1995-05-10
K951347	Marinr Series Ep Diagnosti Catheters	Medtronic Cardiorhythm	DRF	Class II	1995-05-10
K951131	Sunglasses, Nonprescription	Gold, Inc.	HQY	Class I	1995-05-10
K951063	Ati Disposable Test Pack for Eo Gas Sterilization	Pymah Corp.	JOJ	Class II	1995-05-10
K951019	Intraoral Video Scope and Window Tube	Cuda Products Co.	EIA	Class I	1995-05-10
K950823	Andal	Pt. Sarana Indoprotex	LYY	Class I	1995-05-10
K950618	Ace Supracondylar Plate	Ace Medical	HRS	Class II	1995-05-10
K950600	Vacuum Surge Supresser	Surgin Surgical Instrumentation, Inc.	HQC	Class II	1995-05-10
K950208	Nihon Kohden Neuropack Sigma Meb-5500A Evoked Response & EMG Measuring System	Nihon Kohden America Inc	GWF	Class II	1995-05-10
K950043	Jpi Automatic X-Ray Film Processor	JPI Healthcare Co., Ltd	IXW	Class II	1995-05-10
K945630	Large Muscle Strength Gauge	J-Tech, Inc.	KQX	Class I	1995-05-10
K945384	1481 T Digital Telemetry Systems, Enhanced	Siemens Medical Solutions USA, Inc.	DSI	Class II	1995-05-10
K945071	Propaq 200 Monitor	Protocol Systems, Inc.	DRT	Class II	1995-05-10
K944618	Neonatal Blood Collection and Screening Form	General Business Forms, Inc.	JKA	Class II	1995-05-10