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 2026-10-12, 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 261 of 3528

510(k) clearances, page 261 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221093	X-Cube 70, X-Cube 90	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2022-10-14
K220994	Shoulder PacemakerTM	NCS Lab SRL	IPF	Class II	2022-10-14
K220914	Tornier Perform Humeral System – Fracture	TORNIER Inc.	PHX	Class II	2022-10-14
K220318	PAL Infiltration System	MicroAire Surgical Instruments, LLC	QPB	Class II	2022-10-14
K214054	TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520	TP Orthodontics, Inc.	DYH	Class II	2022-10-14
K213857	HeartFlow Analysis	Heartflow, Inc.	PJA	Class II	2022-10-14
K213748	CoreLevee	Lutronic Corporation	NGX	Class II	2022-10-14
K213183	Safety Insulin Pen Needles	Zhejiang Kindly Medical Devices Co., Ltd.	FMI	Class II	2022-10-14
DEN210027	The Cooral System	Braincool AB	QUA	Class II	2022-10-14
K222763	Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors	Responsive Arthroscopy	MBI	Class II	2022-10-13
K222473	EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods	Medos International SARL	NKB	Class II	2022-10-13
K222448	UNITY Sacroiliac Joint Fixation System	Dio Medical Co., Ltd.	OUR	Class II	2022-10-13
K222113	Abiomed 14Fr Low Profile Introducer Set	Abiomed, Inc.	DYB	Class II	2022-10-13
K222087	SCIg60 Infusion System	Emed Technologies Corporation	PKP	Class II	2022-10-13
K222081	ID-510 iRestore Elite	Freedom Laser Therapy Inc	OAP	Class II	2022-10-13
K221989	The Oligio	WONTECH Co., Ltd.	GEI	Class II	2022-10-13
K221857	Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201	Zhejiang LuDe Technology Development Co., Ltd.	DXQ	Class II	2022-10-13
K221770	Fiber Laser Treatment System	Shanghai Apolo Medical Technology Co.,Ltd.	ONG	Class II	2022-10-13
K220857	X-Cube 50, X-Cube 60	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2022-10-13
K220853	PicoWay Laser System	Candela Corporation	GEX	Class II	2022-10-13
K220805	VITEK 2 AST-Gram Positive Cefoxitin Screen	bioMerieux, Inc.	LON	Class II	2022-10-13
K220730	allFlex Ureteral Catheters, Krait Ureteral Catheters	Allwin Medical Devices, Inc.	KOD	Class II	2022-10-13
K213396	SPIFE A1AT kit	Helena Laboratories, Corp.	OBZ	Class II	2022-10-13
K212702	IM/ST Fixture System	Guilin Fiteeth Medical Instrument Co., Ltd.	DZE	Class II	2022-10-13
K211427	CREOKORREKT Aligners	Creodent Prosthetics Ltd	NXC	Class II	2022-10-13
K211321	Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)	Guangzhou Sonostar Technologies Co., Ltd.	IYN	Class II	2022-10-13
K222068	Durex Penck III Regular	Rb Health (Us), LLC	HIS	Class II	2022-10-12
K222064	The Alma Soprano Titanium	Alma Lasers Ltd.	GEX	Class II	2022-10-12
K221913	Arm Blood Pressure Monitor	Alicn Medical Shenzhen, Inc	DXN	Class II	2022-10-12
K221712	Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)	Fotona d.o.o.	GEX	Class II	2022-10-12
K221576	Ameda Pearl Electric Breast Pump	Ameda, Inc.	HGX	Class II	2022-10-12
K221510	TrusFIL-Flow Flowable Composite Restorative	Rizhao Huge Biomaterials Company, Ltd.	EBF	Class II	2022-10-12
K221263	Aqua Naina Plus Sterile Saline Solution	Chemtex USA, Inc.	LPN	Class II	2022-10-12
K220924	Elecsys HSV-2 IgG (08948887160)	Roche Diagnostics GmbH	MYF	Class II	2022-10-12
K220923	Elecsys HSV-1 IgG (08948844160)	Roche Diagnostics GmbH	MXJ	Class II	2022-10-12
K220911	Elecsys CMV IgG	Roche Diagnostics GmbH	LFZ	Class II	2022-10-12
K220227	Auto Folding Scooter, S21F	Heartway Medical Products Co., Ltd.	INI	Class II	2022-10-12
K220102	MOST-T Autoclave	Shinva Medical Instrument Co., Ltd.	FLE	Class II	2022-10-12
K213120	OW100S (model OW100S-US)	Tissue Regeneration Technologies, LLC dba AS Softwave Trt	ISA	Class I	2022-10-12
K211872	PiezoImplant System	Rex Implants, Inc	NRQ	Class II	2022-10-12
K203638	AT-Patch ECG Analysis System	ATsens Co., Ltd.	DSH	Class II	2022-10-12
K222744	Sol-M Luer Lock Syringe	Sol-Millennium Medical, Inc.	FMF	Class II	2022-10-11
K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	Cosmedent, Inc.	EBF	Class II	2022-10-11
K222432	IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439	Hunan Guangye Biotechnology Co., Ltd.	OHT	Class II	2022-10-11
K222335	Surgical Mask	Luoyang Sunmed Devices Co., Ltd.	FXX	Class II	2022-10-11
K222157	ECHO Photocoagulator	Norlase ApS	HQF	Class II	2022-10-11
K222079	Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control	Stryker Corp.	GCJ	Class II	2022-10-11
K221951	Branchor Balloon Guide Catheter	Asahi Intecc Co., Ltd.	QJP	Class II	2022-10-11
K221830	Apyx One Console	Apyx Medical Corporation	GEI	Class II	2022-10-11
K220169	SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)	Bionet Co., Ltd.	IYN	Class II	2022-10-11