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 2026-11-05, 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 1225 of 3531

510(k) clearances, page 1225 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061227	Hydrolyzed Collagen/ag Wound Gel with Silver	The Hymed Group Corp.	FRO	Unclassified	2006-12-20
K063600	Vista Avs	Summit Doppler Systems, Inc.	JAF	Class II	2006-12-19
K063499	Modification to Scandius Tritis Tibial Acl Reconstruction System	Scandius Biomedical, Inc.	MBI	Class II	2006-12-19
K063497	Modification to Scandius Tritis Absorbable Tibial Reconstruction System	Scandius Biomedical, Inc.	MAI	Class II	2006-12-19
K063331	Bausch & Lomb Ngx Microsurgical System	Bausch & Lomb Incorporated	HQC	Class II	2006-12-19
K063229	Rest Assured Nite Protector	Ranir LLC	OBR	Unclassified	2006-12-19
K063136	Needleless Sling	Specialities Remeex International, S.L.	PAH	Class II	2006-12-19
K062936	Nobelperfect Conical Connection	Nobel Biocare AB	DZE	Class II	2006-12-19
K062838	Vitros Troponin I Es Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303	Ortho-Clinical Diagnostics, Inc.	MMI	Class II	2006-12-19
K062836	Citadel Anterior Lumbar Plate System	Globus Medical, Inc.	KWQ	Class II	2006-12-19
K062821	U-Clip Device	Medtronic Neurosurgery	FZP	Class II	2006-12-19
K062645	Ruike, Model 3431	Shanghai Ruike Sports Goods Co., Ltd.	INI	Class II	2006-12-19
K062635	Model 2200	Clarimedex, Inc.	ILY	Class II	2006-12-19
K062198	Sunspots Pre-Gelled Surface Electrodes	Axon Systems, Inc.	GXY	Class II	2006-12-19
K062038	X-Sten Mild Tool Kit, Model Mtk-0001	X-Sten Corp.	HRX	Class II	2006-12-19
K063640	Kowa Sl-15	Kowa Co., Ltd.	HJO	Class II	2006-12-18
K063506	Lorenz Sternal Closure System	Biomet Microfixation	HRS	Class II	2006-12-18
K063049	Synthes (USA) Modular Mini Fragment Lcp System	Synthes (USA) Products LLC	HRS	Class II	2006-12-18
K062971	Breath Alcohol Check .02 and Breathscan .02 Detection Systems	Akers Biosciences, Inc.	DJZ	Class I	2006-12-18
K062929	Quest Diagnostics Urine Cocaine Metabolite Eia	Quest Diagnostics, Inc.	DIO	Class II	2006-12-18
K061737	Loss of Resistance Syringe	Robert Busse & Co., Inc.	CAZ	Class II	2006-12-18
K061082	Mobis Spinal Implant	Signus Medizintechnik GmbH	MQP	Class II	2006-12-18
K060795	Somnofit	Strategic Counsel SARL	LRK	Class II	2006-12-18
K060794	Progenix Dbm Putty and Paste	Medtronic Sofamor Danek	MBP	Class II	2006-12-18
K063591	Vitros Chemistry Products Crea Slides,model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208	Ortho-Clinical Diagnostics, Inc.	JFY	Class II	2006-12-15
K063478	Versalok Anchor with Free Strands of Orthocord Suture (210808), Ethibond Suture (210809), and Panacryl Suture (210810)	DePuy Mitek, Inc.	HWC	Class II	2006-12-15
K063446	Catheter Repair Kit with Replacement Connector, Model 5587000	C.R. Bard Inc	NFK	Class II	2006-12-15
K062814	Pipeline II Access System	DePuy Spine, Inc.	GZT	Class II	2006-12-15
K062714	Synthetic Vinyl Patient Exam Gloves, Pre-Powdered, Yellow	Baoding Guanzhong Glove Co., Ltd.	LYZ	Class I	2006-12-15
K062577	V1 Multi-Port Connector, Model Pad V1-Mpc	TZ Medical Inc.	DSA	Class II	2006-12-15
K062551	Nexus Irrigation Tubing Set	Nexus Medical, LLC	LJH	Class II	2006-12-15
K062524	Octax Laser Shot System	Minitube of America, Inc.	MRX	Class II	2006-12-15
K062502	Osspray Cleaning Compound	Ospray, Ltd.	EJR	Class I	2006-12-15
K062460	Vitros Chemistry Products Op Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	DJG	Class II	2006-12-15
K062426	Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners	Depuy Orthopaedics Inc.	KWA	Class III	2006-12-15
K062345	Ceramic Bond	Voco GmbH	EBF	Class II	2006-12-15
K061879	Sdi Ca480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System	Hemodiagnostica, LLC	CFR	Class II	2006-12-15
K061680	Atrium Medical Corporation Clearway Rx Catheter	Atrium Medical Corporation	DQY	Class II	2006-12-15
K061656	Laser-D68	Laser Pain Clinics LP	GEX	Class II	2006-12-15
K061462	Bf+ (Ph)	Ldr Spine USA	MQV	Class II	2006-12-15
K063580	Sonoace X8 Diagnostic Ultrasound System	Medison Co., Ltd.	IYN	Class II	2006-12-14
K063579	2Mp Medical Color Reference Display, Model Mdc2130-2Hc	Chi Lin Technology Co., Ltd.	LLZ	Class II	2006-12-14
K063558	Peak Se, Model 5135	Ultradent Products Inc.	KLE	Class II	2006-12-14
K063482	Crossplan / Accusoft-Xl V.4.04	Direx Systems Corp.	MUJ	Class II	2006-12-14
K063371	Pronto V3 Extraction Catheter, Model 5003	Vascular Solutions LLC	QEZ	Class II	2006-12-14
K063270	Rpm Respiratory Gating System	Varian Medical Systems, Inc.	IYE	Class II	2006-12-14
K063218	E-Check (Xe)	Streck LLC	JPK	Class II	2006-12-14
K063070	Aperfix Tibial Implant with Inserter	Cayenne Medical Inc.	HWC	Class II	2006-12-14
K063034	Air-Flex with Auto-Distraction	Hill Laboratories	JFB	Class II	2006-12-14
K063020	Intai Bone Plate and Bone Screw System; Intai Dhs/dcs Plate System	Intai Technology Corp.	HRS	Class II	2006-12-14