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 1087 of 3531

510(k) clearances, page 1087 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K083393	Xia 3 Spinal System	Howmedica Osteonics Corp	NKB	Class II	2009-04-01
K083310	Spine & Trauma Ict	Brainlab, Inc.	OLO	Class II	2009-04-01
K083098	Navigator Applications Suite	GE Healthcare Finland Oy	BSZ	Class II	2009-04-01
K082796	Sopro 184 Camera	Sopro	GCJ	Class II	2009-04-01
K082080	Alco Tube Plus	Alcotest Quebec	DJZ	Class I	2009-04-01
K081527	Light Diagnostics Hsv 1/2 Typing Dfa Kit	EMD Millipore Corporation	GQL	Class II	2009-04-01
K090722	Shape-HF Cardiopulmonary Exercise Testing System	Shape Medical Systems, Inc	BTY	Class II	2009-03-31
K090644	Vitablocs, Model Vx55-****	Vita Zahnfabrik H.Rauter GmbH & Co.	EIH	Class II	2009-03-31
K090553	Naviscan Pemflex Solo II High Resolution Pet Scanner	Naviscan, Inc.	KPS	Class II	2009-03-31
K090499	Lifedop Model, L350r	Summit Doppler Systems, Inc.	MAA	Class II	2009-03-31
K090492	1.5Mm Small Locking Plate, 1.5Mm Non-Locking and Locking Screws	Depuy Orthopaedics Inc.	HRS	Class II	2009-03-31
K090403	Autospect	Philips North America LLC	KPS	Class II	2009-03-31
K090259	Okamoto Ultra Thin	Okamoto U.S.A., Inc.	HIS	Class II	2009-03-31
K090223	Icad Breast Interventional Planning Software, Model D70024	iCAD, Inc.	LLZ	Class II	2009-03-31
K090106	Prelude One	Danville Materials, Inc.	KLE	Class II	2009-03-31
K090026	Chitogauze, Models 130, 131, 263, 264, 265, 266	Hem Con Medical Technologies, Inc.	QSY	Unclassified	2009-03-31
K083722	Ascend	Caldera Medical, Inc.	OTP	Class III	2009-03-31
K083446	Cardiac Function Analysis, Calcium Scoring	Ziosoft, Inc.	LLZ	Class II	2009-03-31
K083432	Drill Free Mmf Screw	KLS-Martin L.P.	DZL	Class II	2009-03-31
K083114	Acuson P50 Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2009-03-31
K090372	The Wand Microaccess Safety Introducer	Access Scientific, Inc.	DYB	Class II	2009-03-30
K083784	Pronto V3 Extraction Center, Model 5003, Pronto Lp Extraction Catheter, Model 5010, Skyway Rx Support Catheter,	Vascular Solutions LLC	QEZ	Class II	2009-03-30
K083487	Emit 2000 Sirolimus Assay, Emit 2000 Siro/tacro Sample Pretreatment Reagent, and Emit 200 Sirolimus Calibrator	Siemens Healthcare Diagnostics Inc.	NRP	Class II	2009-03-30
K083169	Eptfe Slftm Spiral Vascular Graft	Tayside Flow Technologies Limited	DSY	Class II	2009-03-30
K082719	Nikkline Blood Tubing Lines with Transducer Protectors, Models Av06a-P, Avo6b-P, Av06c-P	Nikkiso Co., Ltd.	KOC	Class II	2009-03-30
K082582	Sentinel, Model Sp-001	C-Rad Positioning AB	IYE	Class II	2009-03-30
K080852	Ksea Electronic CO2 Endoflator Lc, Model 26430320-1	Karl Storz Endoscopy-America, Inc.	HIF	Class II	2009-03-30
K090649	Vrad Picture Archiving and Communications System Software	Virtual Radiologic Corporation	LLZ	Class II	2009-03-27
K090512	Powerport Duo m.r.i. Implanted Port with 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter	C.R. Bard Inc	LJT	Class II	2009-03-27
K090495	Truebalance Blood Glucose System	Home Diagnostics, Inc.	NBW	Class II	2009-03-27
K090410	Cooltouch Thermal Sensing Handpiece Accessory	New Star Lasers, Inc.	GEX	Class II	2009-03-27
K090201	Ua-Cellular for Iq	Streck LLC	JPK	Class II	2009-03-27
K090153	Spi Variomulti Angled Abutment	Thommen Medical AG	NHA	Class II	2009-03-27
K083869	Bt-Tite Cv3, Mini Implant, Mini Single, Slot Implant, Model(s) Dddiii Bticv3, 1, and Dddiiibtisi	Btlock SRL	DZE	Class II	2009-03-27
K083863	Theken Atoll Oct Spinal System	Theken Companies LLC	MNI	Class II	2009-03-27
K083307	Synthasome X-Repair	Synthasome, Inc.	FTL	Class II	2009-03-27
K083266	Gore Bio-a Fistula Plug	W. L. Gore & Associates, Inc.	FTL	Class II	2009-03-27
K083161	Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100)	Conmed Linvatec	HRX	Class II	2009-03-27
K083024	Hylatopic Emollient Foam	Collegium Pharmaceutical Incorporated	MGQ	Unclassified	2009-03-27
K082177	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corporation	FRG	Class II	2009-03-27
K081748	Oneplant Dental Implant System	WARANTEC Co., Ltd.	DZE	Class II	2009-03-27
K090659	Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery	Medtronic, Inc.	DQY	Class II	2009-03-26
K090536	Fora V12 No-Coding Blood Glucose Monitoring System, Model Td-4247	Taidoc Technology Corporation	NBW	Class II	2009-03-26
K090508	The Belmont Buddy Lite Fluid Warmer	Belmont Medical Technologies	BSB	Class II	2009-03-26
K090478	Aos Proximal Humeral Nail	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2009-03-26
K090112	Midas Rex Mr7 Pneumatic High Speed System, Models Pm700, Pm710, Pc700, Pc710, Pc720, Pa700	Medtronic Powered Surgical Solutions	HBB	Class II	2009-03-26
K083739	Hydrorise and Hydrosystem	Zhermack S.p.A.	ELW	Class II	2009-03-26
K083662	Criticool	Mtre Advanced Technology, Ltd.	DWJ	Class II	2009-03-26
K083389	Coalition Spacer	Globus Medical, Inc.	OVE	Class II	2009-03-26
K083020	Stryker Spine Reflex Translational Anterior Cervical Plating System	Stryker Corp.	KWQ	Class II	2009-03-26