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 972 of 3531

510(k) clearances, page 972 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101928	Ventralex St Hernia Patch	C.R. Bard Inc	FTL	Class II	2011-03-23
K101920	Ventrio St Hernia Patch	C.R. Bard Inc	FTL	Class II	2011-03-23
K101852	Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit	Iris International Inc., A Division of Iris Iris I	KQO	Class I	2011-03-23
K101644	Quanta Flash H-Ttg Igg	Inova Diagnostics, Inc.	MVM	Class II	2011-03-23
K110151	Achieva R4 1.5T and Achieva R4 3.0T	Philips Health Care	LNH	Class II	2011-03-22
K103813	Sopro 281	Sopro	NTN	Class II	2011-03-22
K103751	Mustang Balloon Dilatation Catheters	Boston Scientific Corporation	LIT	Class II	2011-03-22
K103711	Orthophos Xg 3D / Ceph	Sirona Dental Systems GmbH	OAS	Class II	2011-03-22
K103696	Erbeflo Clevercap Hybrid Tubing/cap Sets for Olympus Models 160 and 180 Series Scopes	Erbe USA Inc	FEQ	Class II	2011-03-22
K103640	Midmark Iqecg	Brentwood Medical Technology Corp.	DPS	Class II	2011-03-22
K103567	Lifepak 15 Monitor/defibrillator	Physio Control, Inc.	MKJ	Class III	2011-03-22
K103411	Ideal Iq Software Option	GE Healthcare	LNH	Class II	2011-03-22
K102635	Apolonia Laser Implant System	CSM Implant	DZE	Class II	2011-03-22
K102533	Rotating Gamma System Infini (Infini)	Masep Medical Science & Tech.Development (Shenzhen	IWB	Class II	2011-03-22
K101887	Confident Surgery Suite 300, Model Css300	Surgiceye GmbH	IZD	Class I	2011-03-22
K101422	The Power Wand Safety Introducer with an Extended Dwell Catheter	Access Scientific, Inc.	DYB	Class II	2011-03-22
K093046	Elibra Uni Soft-Tissue Force Sensor, Model 61-Xxxx(5 Models, Different Sizes	Synvasive Technology, Inc.	ONN	Class II	2011-03-22
K092138	Jts Extendeable Implant	Stanmore Implants Worldwide, Ltd.	KRO	Class II	2011-03-22
K110501	Hem-4030	Omron Healthcare Co., Ltd.	DXN	Class II	2011-03-21
K110299	Digital Automatic Wrist Blood Pressure Monitor Wbpm10 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2011-03-21
K103721	Mpact Acetabular System	Medacta International SA	LPH	Class II	2011-03-21
K100424	Danmedical Analysis System, Model D-Mas	Danmedical Limited	MWI	Class II	2011-03-21
K110601	Sentinella 102	General Equipment for Medical Imaging, S.A.	IYX	Class I	2011-03-18
K110553	Asahi Treasure Floppy Peripheral Guide Wire	Asahi Intecc USA, Inc.	DQX	Class II	2011-03-18
K110482	Prosound C3 / C3 Cv Ultrasound Systems	Teratech Corp.	IYN	Class II	2011-03-18
K110476	Axsos (Tm) Locking Plate System	Stryker Corp.	HRS	Class II	2011-03-18
K110224	Synthetic Vinyl Examination Glove, Powder Free	Weifang Beihai Color Printing Packagging Co., Ltd.	LYZ	Class I	2011-03-18
K110064	Snap Model 8 Snoring and Apnea Recording and Analysis System	Snap Diagnostics, L.L.C.	MNR	Class II	2011-03-18
K103798	Bd Probetec Herpes Simplex Viruses (Hsv 1& 2) Q Amplified DNA Assays	Becton Dickinson & Co	OQO	Class II	2011-03-18
K103705	Low Profile Screws	Arthrex GmbH	HWC	Class II	2011-03-18
K103579	Intra Skan Dc	Skanray Technologies Limited	EHD	Class II	2011-03-18
K103136	Surgicase Cmf, Surgicase Connect, Surgicase Guide	Materialise N.V.	JEY	Class II	2011-03-18
K102958	Philips Avalon Fetal Monitor	Philips Medizin Systeme Boblingen GmbH	HGM	Class II	2011-03-18
K102779	Emit II Plus6-Acetylmorphine Assay; Emit II Plus 6-Am/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-Am / Ectasy C	Siemens Healthcare Diagnostics Inc.	DJG	Class II	2011-03-18
K102588	Achieve Mapping Catheter and Electrical Cable	Medtronic Ablation Frontiers, LLC	DRF	Class II	2011-03-18
K102586	S9 Vpap Adapt with H5i	ResMed Corp	BZD	Class II	2011-03-18
K102299	CPR Face Mask	Genuine First Aid, LLC	CBP	Class II	2011-03-18
K101916	Joule Multi-Platform System	Sciton, Inc.	GEX	Class II	2011-03-18
K101792	Liv Linde Intergrated Valve-Portable Oxygen System, Model M706	Linde Gas North America, LLC	ECX	Class I	2011-03-18
K110445	Flexfusion (Tm) Fixation Implant	Medartis AG	HWC	Class II	2011-03-17
K110371	Encompass Hf100- Eagle Panoramic/cephalometric X-Ray	Panoramic Corp.	MUH	Class II	2011-03-17
K110028	Masimo Radical Y Pulse Co-Oximeter	Masimo Corporation	DQA	Class II	2011-03-17
K103814	Pezo Interbody Cages System	Ulrich GmbH & Co. KG	MAX	Class II	2011-03-17
K103743	Concorde Curve System	Johnson & Johnson	MAX	Class II	2011-03-17
K103742	Accell Evo3 (Formerly Accell A2i)	Integra Pain Management	MBP	Class II	2011-03-17
K103689	Planmeca Promax 3D Mid	Planmeca Oy	MUH	Class II	2011-03-17
K103664	Primus Aesthetic Platform	Palomar Medical Technologies, Inc.	ONG	Class II	2011-03-17
K103546	Aycan Workstation Osirix Pro	Aycan Digitalsysteme GmbH	LLZ	Class II	2011-03-17
K103440	Everest Spinal System	K2M, Inc	MNI	Class II	2011-03-17
K103416	Nexus Drf Digital X-Ray Imaging System	Infimed, Inc.	OWB	Class II	2011-03-17