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 390 of 3528

510(k) clearances, page 390 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K201225	Neodent Implant System - GM Helix Implants 7.0	JJGC Industria e Comercio de Materiais Dentarios SA	DZE	Class II	2020-09-04
K201134	Arthrex NanoScope System	Arthrex GmbH	GCJ	Class II	2020-09-04
K200835	3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad	3M Company	FRO	Unclassified	2020-09-04
K193655	MSLS6QF TENS/PMS Device	Self Doctor Care, LLC	NUH	Class II	2020-09-04
K193439	MEBO Wound Dressing	Mebo Life Science, Inc.	FRO	Unclassified	2020-09-04
K193341	iCTmotor (WL-1)	Dentium Co., Ltd.	EBW	Class I	2020-09-04
K192538	BD Syringe NRFit Lok and BD Syringe NRFit Slip	Becton Dickinson & Co	QEH	Class II	2020-09-04
K192524	Lumipulse G CA15-3	Fujirebio Diagnostics, Inc.	MOI	Class II	2020-09-04
K190561	NICU V'02	Cosmed Nordic ApS	BZL	Class II	2020-09-04
K202499	Diamond Digital Sleep Orthotic (DDSO)	Diamond Orthotic Laboratory, LLC	LRK	Class II	2020-09-03
K202235	ArtPIX DRF	CMT Medical Technologies, Ltd.	JAA	Class II	2020-09-03
K202176	Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes	Medical Components, Inc.	MSD	Class II	2020-09-03
K201966	7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array	7D Surgical, Inc.	OLO	Class II	2020-09-03
K201900	3D GraftRasp System	Surgentec LLC	FMF	Class II	2020-09-03
K201769	Cavetto [MAX] Cervical Cage System	Neurostructures, Inc.	ODP	Class II	2020-09-03
K201591	Flat Panel Detector	KA Imaging Inc.	MQB	Class II	2020-09-03
K201522	Arthrex Syndesmosis TightRope XP Buttress Plate Implant System	Arthrex GmbH	HTN	Class II	2020-09-03
K201336	DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm	Synthes (USA) Products LLC	JDS	Class II	2020-09-03
K201211	3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+	Shenzhen Beacon Display Technology Co., Ltd.	PGY	Class II	2020-09-03
K201203	Cliq Aspirator	Anest Iwata Sparmax Co., Ltd.	BTA	Class II	2020-09-03
K201074	Delta III Lithotripter	Dornier Medtech America, Inc.	LNS	Class II	2020-09-03
K200641	HaloGUARD Protective Disc with CHG	Attwill Medical Solutions	FRO	Unclassified	2020-09-03
K200212	Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled	Innovative Health, LLC.	MTD	Class II	2020-09-03
K200102	MIS Dental Implant System	Dentsply Sirona Inc	DZE	Class II	2020-09-03
K193599	BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair	21ST Century Scientific, Inc.	ITI	Class II	2020-09-03
K192452	Lyograft	B. Bruan Surgical, SA	FTM	Class II	2020-09-03
K192111	Biodegradable Nitrile Examination Powder Free Glove, Green	Top Glove Sdn. Bhd.	LZA	Class I	2020-09-03
K202216	EPIQ Series Diagnostic Ultrasound Systems	Philips North America LLC	IYN	Class II	2020-09-02
K202215	cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit	Roche Molecular Systems Inc	QMI	Class II	2020-09-02
K202182	ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	Imperative Care Inc.	NRY	Class II	2020-09-02
K202169	Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22	Spectrum Medical Inc	KFM	Class II	2020-09-02
K202124	Aesculap PAS-Port Proximal Anastomosis System	Aesculap Inc	FZP	Class II	2020-09-02
K201765	SmartHDM-510 System	Mesa Laboratories Inc	FIZ	Class II	2020-09-02
K201677	Arthrex Mesh Plates	Arthrex GmbH	HRS	Class II	2020-09-02
K201552	ApolloVue S100 Image System	Apollo Medical Optics, Ltd.	NQQ	Class II	2020-09-02
K201277	Oral-B Dry Mouth Oral Rinse	Procter & Gamble Co.	LFD	Unclassified	2020-09-02
K200833	RX-1 Rhythm Express Remote Cardiac Monitoring System	VivaQuant, Inc	MLO	Class II	2020-09-02
K200827	LOCATOR R-Tx	Ivory Super Holdco, Incp.	NHA	Class II	2020-09-02
K200812	VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter	Philips Image Guided Therapy Corporation	OBJ	Class II	2020-09-02
K200516	OCT-Camera ID 21101A3	Optomedical Technologies GmbH	OBO	Class II	2020-09-02
K200503	ATL Anchors	International Life Sciences	MBI	Class II	2020-09-02
K200462	EtchPro Etching Gel	Belport Company, Inc., Gingi-Pak	KLE	Class II	2020-09-02
K193618	ExactechGPS System	Blue Ortho	OLO	Class II	2020-09-02
K193405	Simplant Digital Guide	Dentsply Sirona Inc	NDP	Class I	2020-09-02
K192830	Bright Temporary C&B	DMP Dental Industry S.A.	EBG	Class II	2020-09-02
K192704	Endofresh Digestive Endoscopy System	Huizhou Xzing Technology Co., Ltd.	FDS	Class II	2020-09-02
K202160	Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2020-09-01
K201920	Endoscope Reprocessor OER-Elite	Olympus Medical Systems Corp.	FEB	Class II	2020-09-01
K201854	CAPOGEN Laser Cap	Nature, Inc.redible, Inc.	OAP	Class II	2020-09-01
K201135	Image1 S CCU, Image1 S 4U Camera Head	Karl Storz Endoscopy-America, Inc.	FET	Class II	2020-09-01