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 2026-11-02, 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 969 of 3531

510(k) clearances, page 969 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101752	Thermo Scientific Cedia Multi-Drug Oft Calibrators	Microgenics Corporation	DKB	Class II	2011-04-08
K101746	Thermo Scientific Cedia Phencyclidine (Pcp) Oft Assay	Microgenics Corporation	LCM	Unclassified	2011-04-08
K101745	Thermo Scientific Cedia Amphetamine Oft Assay	Microgenics Corporation	DKZ	Class II	2011-04-08
K101744	Thermo Scientific Cedia Cannabinoids Oft Assay	Microgenics Corporation	LDJ	Class II	2011-04-08
K101742	Thermo Scientific Cedia Cocaine Oft Assay	Microgenics Corporation	DIO	Class II	2011-04-08
K101581	Intuitive Surgical Da Vinci S Surgical System with Da Vinci Connect & Da Vinci Onsite, Model Is2000	Intuitive Surgical, Inc.	NAY	Class II	2011-04-08
K101377	Smith & Newphew Ultrabraid II Suture	Smith & Newphew, Inc.	GAT	Class II	2011-04-08
K092269	Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control Set	Randox Laboratories, Limited	LDJ	Class II	2011-04-08
DEN100020	Denv Detect Igm Capture Elisa	Inbios Intl., Inc.	OSU	Class II	2011-04-08
K110782	Xvac	Corcym Inc.	CAC	Class II	2011-04-07
K110595	4D Sono-Scan 1.0	TOMTEC Imaging Systems GmbH	LLZ	Class II	2011-04-07
K110353	Mountaineer Oct Spinal System	DePuy Spine, Inc.	KWP	Class II	2011-04-07
K110270	Acculif Cage	Coalign Innovations, Inc.	MAX	Class II	2011-04-07
K110203	Xpert C. Difficle/epi Assay	Cepheid	OMN	Class I	2011-04-07
K110186	Synapse 3D Liver Analysis	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	2011-04-07
K110173	Ems Air-Flow Master Piezon	E.M.S. - Electro Medical Systems SA	ELC	Class II	2011-04-07
K110169	Dimension Vista Cdt Cal, Dimension Vista Cdt Con L, Dimension Vista Cdt Con H	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2011-04-07
K103318	Uni-Vent 731 Series Model Emv+ Portable Critical Care Ventilator	ZOLL Medical Corporation	CBK	Class II	2011-04-07
K102467	Uta and Uha	Uta	NHA	Class II	2011-04-07
K102033	Combitrans Monitoring Sets and Accessories	B.Braun Melsungen AG	DRS	Class II	2011-04-07
K110744	Prontosan Wound Irrigation Solution	B.Braun Medical, Inc.	FRO	Unclassified	2011-04-06
K110499	Cg-5108 Act-3L Continuous ECG Monitor and Arrhythmia Detector	Card Guard Scientific Survival, Ltd.	DSI	Class II	2011-04-06
K110494	Syngo Mbf	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2011-04-06
K110373	Temporomanibular Coil 15	Esaote S.p.A.	MOS	Class II	2011-04-06
K110260	Newtom 5G / Newtom 5G Version Fp	Qr S.r.l.	OAS	Class II	2011-04-06
K103680	Microlife Digital Underarm Thermometer	Microlife Intellectual Property GmbH	FLL	Class II	2011-04-06
K103654	Vela Xl	Starmedtec GmbH	GEX	Class II	2011-04-06
K103604	Isa CO2, Isa Ax+, Isa or+	Phasein AB	CCK	Class II	2011-04-06
K103587	Disposable Bllod Collection Needle	Weihai Hongyu Medical Devices Co., Ltd.	FMI	Class II	2011-04-06
K103368	Hairmax Lasercomb	Lexington International, LLC	OAP	Class II	2011-04-06
K103326	Multiple Biopsy System	United States Endoscopy Group, Inc.	FCK	Class II	2011-04-06
K102542	Resusci Flow; Resusci Flow 104	Atom Medical Corporation	BTL	Class II	2011-04-06
K102225	Alco-Breath Tube, Checkpoint Breath Alcohol Test	AlcoPro Inc	DJZ	Class I	2011-04-06
K100669	Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades	US Medical Innovations, LLC	GEI	Class II	2011-04-06
K100375	Dimension Vista Loci Ca 19-9 Flex Reagent Cartridge, and Dimension Loci7 Calibrator with Model(s) K6457, and Kc604	Siemens Healthcare Diagnostics Inc.	NIG	Class II	2011-04-06
K110378	Impression Compound	SpofaDental A.S.	ELW	Class II	2011-04-05
K110262	Sharps Container	Noble Marketing	MMK	Class II	2011-04-05
K110178	Estelite Color	Tokuyama Dental Corporation	EBF	Class II	2011-04-05
K110055	Reverse Medical Reflex Guide Catheter	Reverse Medical Corporation	DQY	Class II	2011-04-05
K103626	Cutera Genesisplus Laser System	Cutera Inc	PDZ	Class II	2011-04-05
K103370	Rt200	Restorative Therapies Inc.	GZI	Class II	2011-04-05
K103262	Quickdraw Convertible Fixation Implant System	TORNIER Inc.	MBI	Class II	2011-04-05
K103248	Integrity Spinal Care System	Integra Pain Management	ITH	Class II	2011-04-05
K102985	V60 Ventilator with Ppv and Auto-Trak+ Software Options	Respironics, Inc.	MNT	Class II	2011-04-05
K102552	Hemosil La Positive Control	Instrumentation Laboratory Co.	GGC	Class II	2011-04-05
K101057	Aquamantys Double Cone Bipolar Sealer Model: 23-310-1	Salient Surgical Technologies, Inc.	GEI	Class II	2011-04-05
K100767	Trojan Supra Lubricated Polyurethane Male Condom	Church & Dwight Co., Inc.	MOL	Class II	2011-04-05
K110483	Modified Hd Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2011-04-04
K110255	Sound Surgical Technologies Llc Powerx Lipo System	Solta Medical, Inc.	QPB	Class II	2011-04-04
K110185	Nitrile Powder Free Patient Examination Gloves	Tangshan Baojie Glove Co., Ltd.	LZA	Class I	2011-04-04