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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 691 of 3530

510(k) clearances, page 691 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K151302	Clinpro Varnish	3M Company	LBH	Class II	2015-09-18
K151189	Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System	Devon Medical Products	JOW	Class II	2015-09-18
K151095	Circumplast Circumcision Device	Novadien Healthcare	HFX	Class II	2015-09-18
K150639	AF541 EE Full Face Mask	Respironics, Inc.	BZD	Class II	2015-09-18
K150638	AF541 SE Full Face Mask	Respironics, Inc.	CBK	Class II	2015-09-18
K150392	PROPEL device	Propel Orthodontics, LLC	DZJ	Class II	2015-09-18
K143743	ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH	C.R. Bard Inc	FTL	Class II	2015-09-18
K143720	Dimension Vista MMB Assay	Siemens Healthcare Diagnostics Inc.	JHY	Class II	2015-09-18
K143696	Spirit	KaVo Dental Technologies, LLC	EIA	Class I	2015-09-18
K143677	DeVilbiss Intellipap2/DeVilbiss BLUE	Sunrise Medical, Inc.	BZD	Class II	2015-09-18
K142293	Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls	Biophor Diagnostics, Inc.	LAF	Class II	2015-09-18
K152328	FreeStyle InsuLinx Blood Glucose Monotioring System	Abott Laboratories	LFR	Class II	2015-09-17
K152131	Reliance Spinal Screw System	Reliance Medical Systems, LLC	MNI	Class II	2015-09-17
K152098	ODALYS Pedicle Screw System	Kisco International	MNI	Class II	2015-09-17
K152031	New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.	New Deantronics Taiwan Ltd.	GEI	Class II	2015-09-17
K151727	Everest Spinal System	K2M, Inc	NKB	Class II	2015-09-17
K151522	DEFENDO Bronchoscopy Suction Valve	Medivators Inc	KTI	Class II	2015-09-17
K151471	Radifocus Glidewire Endoscopic Wire	Terumo Medical Corp.	OCY	Class II	2015-09-17
K151188	BodyGuardian Remote Monitoring System	Preventice	DSI	Class II	2015-09-17
K151071	SmartLinx Vitals Plus Patient Monitoring System	Capsule Technologie SAS	MWI	Class II	2015-09-17
K150965	LeForte System II	Jeil Medical Corporation	JEY	Class II	2015-09-17
K150958	LifePearl Microshperes	Terumo Cardiovascular Systems Corporation	KRD	Class II	2015-09-17
K150765	LDR Spine ROI-C Cervical Cage System	Ldr Spine USA	OVE	Class II	2015-09-17
K143640	KSEA CMOS Camera System (C-cam)	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	2015-09-17
K152346	MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)	Siemens Healthcare Diagnostics Inc.	JWY	Class II	2015-09-16
K152142	RECON system - MPJ-Plates	Normed Medizin-Technik GmbH	HRS	Class II	2015-09-16
K152052	Ultrasound Scanner System bk2300	BK Medical ApS	IYN	Class II	2015-09-16
K152032	ELUMI 810 + 980 Soft Tissue Laser	Azena Medical	GEX	Class II	2015-09-16
K152030	Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)	Qingdao Hisense Medical Equipment Co.,Ltd.	PGY	Class II	2015-09-16
K151887	syngo VSim	Siemens Medical Solutions USA, Inc.	MUJ	Class II	2015-09-16
K151400	Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products	Jk-Holding GmbH	LEJ	Class II	2015-09-16
K150899	Straumann CARES Titanium Alloy (TAN) Abutment	Straumann USA, LLC	NHA	Class II	2015-09-16
K150720	Xp3000	BTL Industries, Inc	PBX	Class II	2015-09-16
K150594	Biodesign Otologic Repair Graft	Cook Biotech Incorprated	KHJ	Class II	2015-09-16
K150382	Radio Therapy Treatment Chair	Radiation Products Design, Inc.	IYE	Class II	2015-09-16
K150067	OTSC Proctology	Ovesco Endoscopy AG	PKL	Class II	2015-09-16
K143557	SupaScoota Motorized vehicle	Eurogreen International, Inc.	INI	Class II	2015-09-16
K143450	Ackermann Intervertebral Body Fusion Device	Ackermann Instrumente GmbH	ODP	Class II	2015-09-16
K143349	Gynomunal	Polichem SA	NUC	Class II	2015-09-16
K143051	ArgenIS Titanium Abutments	The Argen Corporation	NHA	Class II	2015-09-16
K142530	Partial Knee Application (PKA)	Mako Surgical Corp.	OLO	Class II	2015-09-16
K151655	CO2RE System	Syneron Medical, Ltd.	GEX	Class II	2015-09-15
K151630	G.o.c.c.l.e.s.	Pierrel Pharma S.r.l.	NXV	Class II	2015-09-15
K151554	Occlusion Perfusion Catheter	Advanced Catheter Therapies, Inc.	QEY	Class II	2015-09-15
K151245	Rhythm View Workstation (non-streaming, steaming option)	Topera, Inc.	DQK	Class II	2015-09-15
K150111	Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series	Apex Medical, Inc.	BZD	Class II	2015-09-15
K141177	Vitala Porcine Derived Collagen Membrane	Osteogenics Biomedical, Inc. (Formerly Obi Biologi	NPL	Class II	2015-09-15
K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0	GE Healthcare	IYN	Class II	2015-09-14
K151645	MAMMOMAT Fusion	Siemens Medical Solutions USA, Inc.	MUE	Class II	2015-09-14
K151208	Powder Free Nitrile Examination Glove	Vrg Khai Hoan Joint Stock Company	LZA	Class I	2015-09-14