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 2026-10-29, 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 798 of 3530

510(k) clearances, page 798 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K124033	Medisiss Reprocessed Ultrasonic Instruments	Surgical Instruments Service and Savings, Inc.	NLQ	Unclassified	2014-01-07
K133826	Intonemv	Incontrol Medical, LLC	KPI	Class II	2014-01-06
K133686	21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)	JVCKENWOOD Corporation	LLZ	Class II	2014-01-06
K132830	Distalock Tibial Im Nail System	Dgimed Ortho, Inc.	HSB	Class II	2014-01-06
K132769	Acumed Hand Plating System	Acumed LLC	HRS	Class II	2014-01-06
K132685	Ultrasound Scanner Pro Focus 2202	BK Medical ApS	IYN	Class II	2014-01-06
K132439	Sakura Steam Sterilizer Assr; -Ao12, -A012w, -Ao12p,-Ao12pw / Skytron Integrity 270;Steam Sterilizer,vp Steam Sterilizer	Sakura Seiki Co., Ltd.	FLE	Class II	2014-01-06
K131469	Acon on Call Diabetes Management Software	Acon Laboratories, Inc.	NBW	Class II	2014-01-06
K131461	Lightstim for Acne/ Lightstim for Acne Mini	LED Intellectual Properties LLC	OLP	Class II	2014-01-06
K131276	Lateral Synfix	Synthes (USA) Products LLC	OVD	Class II	2014-01-06
K123262	Optiflux Ultra Dialyzer	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2014-01-06
K133714	Tru Flu	Meridian Bioscience Inc	PSZ	Class II	2014-01-03
K133645	Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2014-01-03
K133312	Expect Slimline Endoscopic Ultrasound Aspiration Needle	Boston Scientific Corporation	ODG	Class II	2014-01-03
K133224	Y-Knot Rc All-Suture Anchor, 2.8Mm - Double Loaded and Triple Loaded W/ #2 Hifi Sutures	ConMed Corporation	MBI	Class II	2014-01-03
K133146	Bausch + Lumb, Vis100 Injector System	Bausch & Lomb Incorporated	MSS	Class I	2014-01-03
K132923	Fusion Single Link	Angelus Industria de Productos Odontologicos	KLE	Class II	2014-01-03
K132733	Orthohelix Syndesmosis Fixation Devices	TORNIER Inc.	HTN	Class II	2014-01-03
K132399	Elitech Clinical Systems Creatinine Pap Sl, Elical 2, Elitrol I and Elitrol II, Urine Control Bi-Level	ELITechGroup Inc	JFY	Class II	2014-01-03
K131880	Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device System	SPINEFRONTIER, Inc. dba LESspine Innovations	OVE	Class II	2014-01-03
K131516	Prismaflex System 7.10	Gambro Renal Products	KDI	Class II	2014-01-03
K131272	Siren Epcr Suite	Medusa Medical Technologies, Inc.	DXJ	Class II	2014-01-03
K130998	Syngo.via Web Viewer	Siemens AG Medical Solutions	LLZ	Class II	2014-01-03
K130937	Wave 2G, Soul	Hansaton Akustik GmbH	KLW	Class II	2014-01-03
K130606	Fmwand Ferromagnetic Surgical System	Omni-Guide Holdings, Inc.	HGI	Class II	2014-01-03
K133512	Loci Vitamin B12 (Vb12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2014-01-02
K133393	Gelpoint Path Transanal Access Platform	Applied Medical Resources Corp	FER	Class II	2014-01-02
K132969	Spec Model M15	Source Production and Equipment Co., Inc.	KXK	Class II	2014-01-02
K132661	Lightscalpel	Lightscalpel Inc	GEX	Class II	2014-01-02
K131364	Flexible Cmos-Video-Cysto-Urethroscope	Karl Storz Endoscopy-America, Inc.	FBO	Class II	2014-01-02
K130901	Somatom Definition as Open	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-01-02
K130670	Hydrofera Blue Pu Bacteriostatic Dressing	Hydrofera, LLC.	FRO	Unclassified	2014-01-02
K133806	M1 Capnography Mask	Monitor Mask, Inc.	CCK	Class II	2013-12-31
K133081	Trochanteric Nails and Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N	Advanced Orthopaedic Solutions, Inc.	HSB	Class II	2013-12-31
K133026	Unballoon Non-Occlusion Modeling Catheter	LeMaitre Vascular Inc.	DQY	Class II	2013-12-31
K132629	Reprocessed Dilating Tip Trocars	Stryker Sustainability Solutions	NLM	Class II	2013-12-31
K132520	Nasal Ease Allergy Blocker	Hi-Tech Pharmacal, Inc.	NUP	Class II	2013-12-31
K131053	Anspach Xmax, Emax2 and Emax2 Plus System with Otologic Attachment System	The Anspach Effort, Inc.	ERL	Class II	2013-12-31
K133490	G-Scan Brio	Esaote S.p.A.	LNH	Class II	2013-12-30
K132875	Compressyn Staple	Dallen Medical, Inc.	JDR	Class II	2013-12-30
K132867	Surelock All-Suture Anchor with Inserter, 1.4Mm, Surelock All-Suture Anchor with Inserter, 2.2Mm	Cayenne Medical Inc.	MBI	Class II	2013-12-30
K132747	Visum Blade LED Surgical Lighting System	STRYKER Communications, Inc.	FSY	Class II	2013-12-30
K132559	Monument Spacers	Globus Medical, Inc.	OVD	Class II	2013-12-30
K132308	Cliq Dv-300 Aspirator	Ding Hwa Co., Ltd.	JCX	Class II	2013-12-30
K133505	Sonoace R7 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	IYN	Class II	2013-12-27
K132674	Bd Phoenix Automated Microbiology System- Meropenem (0.125-32 Ug/ml)	Becton Dickinson & Co	LON	Class II	2013-12-27
K132481	Easy-Load Lens Delivery System	Bausch & Lomb Incorporated	MSS	Class I	2013-12-27
K132007	Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red, Stericycle Sharps Management Services Reu	Stericycle, Inc.	MMK	Class II	2013-12-27
K131789	Cerebralogik- Aeeg	Mennen Medical, Inc.	OMA	Class II	2013-12-27
K131259	Laser-Stim	Shenzhen Dongdixin Technology Co., Ltd.	ILY	Class II	2013-12-27