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 826 of 3530

510(k) clearances, page 826 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121445	Tetrachrome Reagents and Tetracxp System	Siemens Healthcare Diagnostics Inc.	OYE	Class II	2013-07-26
K131974	Healix Advance Knotless Br Anchor (6.5Mm)	DePuy Mitek, Inc.	MAI	Class II	2013-07-25
K131812	Sensis, Sensis Lite	Siemens Medi Cal Solutions, Inc.	DQK	Class II	2013-07-25
K131620	Jones-Fx Fracture System	Instratek, Inc.	HWC	Class II	2013-07-25
K131498	Iqqa-Liver Multimodality Software	Edda Technology, Inc.	LLZ	Class II	2013-07-25
K131475	Barricade Embolization Coil System	Blockade Medical	HCG	Class II	2013-07-25
K131159	Smartrelief	Chattem, Inc.	NUH	Class II	2013-07-25
K130859	Hammertoe Correction System	Arthrosurface, Inc.	HWC	Class II	2013-07-25
K130706	Duoflex Coil Suite (1.5T)	Mr Instruments, Inc.	MOS	Class II	2013-07-25
K130431	Compressyn Band	Dallen Medical, Inc.	JDQ	Class II	2013-07-25
K130158	M-Scan	Bio-Research Associates, Inc.	KZM	Class II	2013-07-25
K130001	Care Su01a Suction Aspirator	Foshan Care Medical Technology Co., Ltd.	JCX	Class II	2013-07-25
K123027	Capstone(r) Spinal System	Medtronic Sofamor Danek	MAX	Class II	2013-07-25
DEN130032	Xpert Mtb/rif Assay	Cepheid	PEU	Class II	2013-07-25
K132087	Percunav System	Philips Health Care	JAK	Class II	2013-07-24
K131964	Bio-Console 560 Extracorporeal Blood Pumping Console	Medtronic, Inc.	DWA	Class II	2013-07-24
K131742	Hem-6131	Omron Healthcare Co., Ltd.	DXN	Class II	2013-07-24
K131690	M7/m7t Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co.,LTD	IYO	Class II	2013-07-24
K131561	Sam Junctional Tourniquet	Sam Medical Products	DXC	Class II	2013-07-24
K131542	Neutrophase(r) Skin and Wound Cleanser OTC	Novabay Pharmaceuticals, Inc	FRO	Unclassified	2013-07-24
K131343	Reform Pedicle Screw System	Spinal USA	MNI	Class II	2013-07-24
K131263	Xperguide	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-07-24
K130962	R&d 5D Retic Hematology Control	R & D Systems, Inc.	JPK	Class II	2013-07-24
K130667	Powderfree Latex Examination Gloves Coated with Allogel	Preventive Care, Inc.	LYY	Class I	2013-07-24
K130305	Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size	LiNA Medical Inc	HIN	Class II	2013-07-24
K130125	Mta Cements	S&C Polymer Silicon- und Composite Spezialitaeten	KIF	Class II	2013-07-24
K123714	Edwards Embol-X Introducer Sheath	Edwards Lifesciences LLC	DYB	Class II	2013-07-24
K132062	Esie Apps Suite	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2013-07-23
K131822	Ultraextend Usws-900A V2.1 and V3.1	Toshiba America Medical Systems, In.C	LLZ	Class II	2013-07-23
K131816	Sorin Connect Data Management System	LivaNova Deutschland GmbH	DXJ	Class II	2013-07-23
K130986	Frag-Loc System	Acumed LLC	HTN	Class II	2013-07-23
K130862	Cavitron Prophy-Jet Air Polishing Prophylaxis System	Dentsply Intl.	ELC	Class II	2013-07-23
K130740	Nightingale Monitoring System	Zoe Medical, Inc.	MWI	Class II	2013-07-23
K130702	Airsonett Air-4	Airsonett AB	FRF	Class II	2013-07-23
K130648	Forum Glaucoma Workplace	Carl Zeiss Meditec Inc	NFJ	Class II	2013-07-23
K130207	Spacelabs Healthcare Cardioexpress	GE Healthcare	DPS	Class II	2013-07-23
K123807	Sharpscan	Medical Engineering Development Solutions, Inc.	MMK	Class II	2013-07-23
K123631	Mfp-051	GC America Inc.	EBF	Class II	2013-07-23
K131572	Micro Ambulatory ECG Recorder	Dimetek Digital Medical Technologies, Ltd.	DPS	Class II	2013-07-22
K131306	Ic-1545-Dl Multi Flo Dvt Combo Intermittent Pneumatic Compression Device	Bio Compression Systems, Inc.	JOW	Class II	2013-07-22
K131191	4Mm & 5Mm Full Radius Blade Plus, 4Mm & 5Mm Barrel Bur Plus/4mm Barrel Tornado Bur Plus, 4Mm & 5Mm Aggressive Blade Plus	DePuy Mitek, Inc.	HRX	Class II	2013-07-22
K130750	Rhythmia Mapping System	Rhythmia Medical, Inc.	DQK	Class II	2013-07-22
K130220	Mr Conditional Presson Electrode	Rhythmlink International, LLC	GXZ	Class II	2013-07-22
K123418	Gram-Negative Quickfish Bc	Advandx, Inc.	JSS	Class I	2013-07-21
K131811	Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups	Ucp Biosciences, Inc.	DKZ	Class II	2013-07-19
K131332	Cardiosolutions Percu-Pro Steerable Introducer	Cardiosolutions, Inc.	DYB	Class II	2013-07-19
K131203	Ihealth Cloud	Andon Health Co., Ltd	DXN	Class II	2013-07-19
K131130	Navigation Pin	Evergreen Orthopedic Research Lab	OLO	Class II	2013-07-19
K130731	Stabiliz Fixation System - Spl Locking Screw	Stabiliz Orthopaedics	HRS	Class II	2013-07-19
K130658	Elixbo Pm545	Xbo Medical Systems Co., Ltd.	LNH	Class II	2013-07-19