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 756 of 3530

510(k) clearances, page 756 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K140735	Evolution Mp Cs/cr Porous Femur/evolution Adaptive Cs and Ps Inserts	Microport Orthopedics Inc.	MBH	Class II	2014-08-29
K140490	Civa Sheet Pd-103	CivaTech Oncology Inc.	KXK	Class II	2014-08-29
K140342	Qct Pro Asynchronous Calibration Module, Cliniqct	Mindways Software, Inc.	KGI	Class II	2014-08-29
K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers Ltd.	GEX	Class II	2014-08-29
K133741	ACCU-CHEK Performa Blood Glucose Monitoring System	Roche Diagnostics GmbH	NBW	Class II	2014-08-29
K132943	Intracardic Catheter Introducer Kit and Transseptal Needle	Synaptic Medical Corporation	DRC	Class II	2014-08-29
K132855	Heartway Power Mobility Scooter	Heartway Medical Products Co., Ltd.	INI	Class II	2014-08-29
K132631	Eia Smdp Immunoassay	Phadia AB	LKP	Class II	2014-08-29
K142166	Total Shield Surgical;toga(regular, Large,x-Large);hood; Helmet Advanced Helmet W/led Lighting, Total Shield Accessories	Zimmer GmbH	FYA	Class II	2014-08-28
K142135	Reduce Fracture Plating System Line Extension	Icon Orthopedic Concepts, LLC dba Edge Orthopaedic	HRS	Class II	2014-08-28
K142120	Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip	AtriCure, Inc.	FZP	Class II	2014-08-28
K142086	Nio -Intraosseous Device	Waismed Ltd.	FMI	Class II	2014-08-28
K142080	Non-Sterile Ors Warning Drapes/slush+warmer Disc-Drape/slush+warmer Palte-Drape /Fluid Warmer Drape,skirted	Microtek Medical LLC	LHC	Class I	2014-08-28
K141821	Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset	Exactech, Inc.	LZO	Class II	2014-08-28
K141573	Silverlon Island Wound Dressing	Argentum Medical, LLC	FRO	Unclassified	2014-08-28
K141443	Infront Lumbar Interbody Fusion System	Infront Medical, LLC	MAX	Class II	2014-08-28
K140892	Distal Elbow Plating System	Skeletal Dynamics, Inc	HRS	Class II	2014-08-28
K140582	Fingertip Pulse Oximeter	Shenzhen Jumper Medical Equipment Co.,Ltd.	DQA	Class II	2014-08-28
K140204	Jwx-2	Yamaha Motor Co Ltd	ITI	Class II	2014-08-28
K140168	Easystim Tn28_otc	Easymed Instruments Co., Ltd.	NUH	Class II	2014-08-28
K141762	Perfuse Percutaneous Decompression System	Zimmer GmbH	FMF	Class II	2014-08-27
K141435	Opal Chiro, 20/20 P-Dr	2020 Imaging	MQB	Class II	2014-08-27
K141318	Cianna Medical Sgs System	Cianna Medical, Inc.	PDW	Class II	2014-08-27
K141307	Aok Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Aok Plastic Co., Ltd.	LYZ	Class I	2014-08-27
K141305	Richful Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Richful Plastic Co., Ltd.	LYZ	Class I	2014-08-27
K141239	Litong Powder-Free Yellow Vinyl Patient Examination Gloves	Zibo Litong Plastic Products Co., Ltd.	LYZ	Class I	2014-08-27
K141230	Doselab Pro	Mobius Medical Systems, LP	IYE	Class II	2014-08-27
K141162	All-Ceramic Zirconia Block	Rizhao Huge Dental Industry Co., Ltd.	EIH	Class II	2014-08-27
K140862	Monica Novii Wireless Patch System	Monica Healthcare	OSP	Class II	2014-08-27
K140850	Genesis Reusable Rigid Container System	Medtronic, Inc.	KCT	Class II	2014-08-27
K140338	Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)	Creganna-Tactx Medical	DYB	Class II	2014-08-27
K133724	Minncare Hd	Medivators Inc	NIH	Class II	2014-08-27
K133549	Steritec Biological Test Pack with Instant Readout Integrator	Steritec Products Mfg. Co., Inc.	FRC	Class II	2014-08-27
K133023	Jetstream Xc 2.4/3.4; Jetstream Xc 2.1/3.0; Jetstream Sc 1.85; Jetstream Sc 1.6	Medrad, Inc.	MCW	Class II	2014-08-27
K132380	Prevantics Device Swab	Professional Disposables International, Inc.	LKB	Unclassified	2014-08-27
K141505	Basal Digital Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	2014-08-26
K141497	Portable X-Ray System (Model:exaro,xray2go)	OSSTEM Implant Co., Ltd.	EHD	Class II	2014-08-26
K141451	VixWin Platinum	Imaging Sciences International (dba Gendex, LLC)	LLZ	Class II	2014-08-26
K141291	Vertiform Posterior Fixation System	Next Orthosurgical	NKB	Class II	2014-08-26
K141095	Stryker Steri-Shield Flyte Hybrid Togas	Stryker Corp.	FYA	Class II	2014-08-26
K141021	Powder-Free Nitrile Examination Gloves, Orange, Color	HL Rubber Industries Sdn Bhd	LZA	Class I	2014-08-26
K140458	Diotech Laser Fiber	Diotech Co	GEX	Class II	2014-08-26
K140305	Caya Contoured Diaphragm	Kessel Medintim GmbH	HDW	Class II	2014-08-26
K133979	TENS	Sunmas (H.K.) Trading Limited	NUH	Class II	2014-08-26
K133678	Confirm Bioactive	Globus Medical, Inc.	MQV	Class II	2014-08-26
K133667	Slit Lamp Sl-D701	Topcon Corp.	HJO	Class II	2014-08-26
K133334	Veritract Enteral Feeding Tube System	Veritract, Inc.	KNT	Class II	2014-08-26
K142044	Cr3 Keyless Split Sample Cup Phencyclidien - Methylenedioxymethamphetamine	Guangzhou Wondfo Biotech Co., Ltd.	LCM	Unclassified	2014-08-25
K142036	Infusomat Space Volumetric Infusion Pump Administration Sets	B.Braun Medical, Inc.	FPA	Class II	2014-08-25
K141553	Medela Thopaz+	Medela AG	BTA	Class II	2014-08-25