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 1261 of 3531

510(k) clearances, page 1261 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K060299	Art Brachytherapy Applicator	Advanced Radiation Therapy, LLC	JAQ	Class II	2006-06-06
K060201	Olympus RF Latex Calibrator, and Olympus RF Latex Reagent with Model(s): Odc0028, and Osr61105.	OLYMPUS Corporation of the Americas	DHR	Class II	2006-06-06
K053464	Service Manager Sm40se	Conmed Integrated Systems, Canada, ULC	FYD	Class II	2006-06-06
K053159	Vectorvision Spine	Brainlab, Inc.	HAW	Class II	2006-06-06
K053034	Acro Biotech Llc Rapid Tetrahydrocannabinol Urine Test; Catalog# Opi001000	ACRO BIOTECH Inc.	LDJ	Class II	2006-06-06
K053033	Acro Biotech Llc Rapid Methamphetamine Urine Test; Catalog# Met001000	ACRO BIOTECH Inc.	DJC	Class II	2006-06-06
K052798	Capsuls, Models 2003-Pur8c, 2004-Pvc8c	Isovac Products LLC	LGN	Class II	2006-06-06
K052601	Stockert Heater-Cooler System 3T	LivaNova Deutschland GmbH	DWC	Class II	2006-06-06
K061426	Oxygen Concentrator Filters, Models Dbf32, Dbf24, Dbf27, Dbf25, Dfc06 and Ddf47	Pentair Filtration Solutions	CAH	Class II	2006-06-05
K061351	Oral-B Sonic Complete	Braun GmbH	JEQ	Class I	2006-06-05
K061308	Trimax, Model 9515N, Breathable Surgical Gown, Models 3247An and 9015N and Optima or Surgical Gown, Model 9506N	Medtronic, Inc.	FYA	Class II	2006-06-05
K061235	Lifestent Turbo Biliary Stent System	Edwards Lifesciences LLC	FGE	Class II	2006-06-05
K061035	Tigerview Professional	Televere Systems	LLZ	Class II	2006-06-05
K061006	Ikoengelo	Ikoetech, LLC	KPQ	Class II	2006-06-05
K060937	Brilliance Volume	Philips North America LLC	JAK	Class II	2006-06-05
K060885	Model Mi 44 Tympanometer	MAICO Diagnostics GmbH	EWO	Class II	2006-06-05
K060862	Ge Datex-Ohmeda Engstrom Carestation	GE Healthcare	CBK	Class II	2006-06-05
K060347	B&l L-Beta, Model Wl-B1	B&L Biotech Co., Inc	EKR	Class I	2006-06-05
K052469	Glucopack	Healthpia America Corp.	NBW	Class II	2006-06-05
K061381	Lc Star with Nasal Adapter	Pari Innovative Manufacturers, Inc.	CAF	Class II	2006-06-02
K061322	Porcelain Primer	J. Morita USA, Inc.	KLE	Class II	2006-06-02
K061320	R&d Lh-Nrbc Hematology Control	R & D Systems, Inc.	JPK	Class II	2006-06-02
K061314	Bard Extra Large Composix Kugel Hernia Patch	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	2006-06-02
K061282	Access Ultrasensitive Hgh Calibrator, Model 33585	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2006-06-02
K061249	Axsym Digoxin III	Abbott Medical	KXT	Class II	2006-06-02
K061240	Sherlock Tip Location System (Tls) Detector and Accessories	Lucent Medical Systems	LJS	Class II	2006-06-02
K061171	Sequitor Steerable Guidewire, Models Sqr18xx and Sqr14xx	Biosphere Medical, S.A.	DQX	Class II	2006-06-02
K061079	Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762 Hemostatic Granules	Medtrade Products Ltd.	QSY	Unclassified	2006-06-02
K061073	Clever Check Td-3250 Blood Glucose and Blood Pressure Measurement System, Model Td-3250	Taidoc Technology Corporation	DXN	Class II	2006-06-02
K061031	D 100 L001 Ph.i.s.i.o.: Newborn Hollow Fiber Membrane Oxygenator with Integrated Hardshell Cardiotomy/venous Reservoir W	Corcym Inc.	DTZ	Class II	2006-06-02
K060744	O'brien Mpa (Mandibular Positioning Applicance)	O'Brien Dental Lab, Inc.	LRK	Class II	2006-06-02
K060732	Mbcp Gel	Biomatlante	LYC	Class II	2006-06-02
K060721	Lariat Loop Applicator	Sentreheart, Inc.	GAT	Class II	2006-06-02
K060670	Accin Uni-Knee System	Accin Corporation	HSX	Class II	2006-06-02
K060641	Platelia Aspergillus Eia, Model 62793	Bio-Rad	NOM	Class I	2006-06-02
K060563	Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV	Pajunk GmbH Medizintechnologie	CAZ	Class II	2006-06-02
K060536	Osteomed 1St Mpj Hemi Implant System	Osteomed	KWD	Class II	2006-06-02
K060138	Synthes (USA) Craniomaxillofacial Distraction System	Synthes (USA) Products LLC	MQN	Class II	2006-06-02
K060053	Stockert S5 System	LivaNova Deutschland GmbH	DTQ	Class II	2006-06-02
K060002	Ritract Safety Syringe	Ritract, Ltd.	MEG	Class II	2006-06-02
K053305	Senstouch Powdered Examination Gloves, Non Sterile	Pt Mahakarya Inti Buana	LYY	Class I	2006-06-02
K051342	Medical Interporous	Bonyf AG	EFT	Class I	2006-06-02
K061189	Dp-9900 Digital Ultrasonic Diagnostic Imaging System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2006-06-01
K061183	Confluent Surgical Dual Liquid Applicator, Model 70-2005-093	Confluent Surgical,Inc	FMF	Class II	2006-06-01
K061129	Ge Logiq 9, Models 2188900, 2375600, 2404587 and 5150000	General Electric Co.	IYN	Class II	2006-06-01
K052254	Mytis Arrow Xxxx	Brainbase Corporation	DZE	Class II	2006-06-01
K061343	Inspirstar Glove Electrode	Inspirstar, Inc.	GXY	Class II	2006-05-31
K061253	Reflection 3 Acetabular System	Smith & Nephew, Inc.	MBL	Class II	2006-05-31
K061251	Dimension Vista Total Iron Binding Capacity Calibrator	Siemens Healthcare Diagnostics Inc.	JIS	Class II	2006-05-31
K061199	Oral B Professionalcare Series, Oral B Advancepower Series	Braun GmbH	JEQ	Class I	2006-05-31