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 841 of 3530

510(k) clearances, page 841 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130335	Mastergraft Strip; Mastergraft Ultramatrix	Medtronic Sofamor Danek USA Inc	MQV	Class II	2013-04-19
K130269	Ecat Scintron Pet	Miegmbh	KPS	Class II	2013-04-19
K130167	Profemur Xm Distal Centralizer	Wrightmedicaltechnologyinc	LZO	Class II	2013-04-19
K130108	Double Engine Bone Plate and Screw Systems	Xiamen Double Engine Medical Material Co., Ltd.	HRS	Class II	2013-04-19
K130063	Arcos Trochanter Button	Zimmer GmbH	LPH	Class II	2013-04-19
K123716	Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit	Applied Medical Technology Inc	KNT	Class II	2013-04-19
K123552	Instinct Java System	Zimmer Spine, Inc.	NKB	Class II	2013-04-19
K122868	Biosphere Bioactive Bone Graft Putty	Synergy Biomedical	MQV	Class II	2013-04-19
K122539	Measurement of Ph in Pleural Fluid on Blood Gas System	Siemens Healthcare Diagnostics Inc.	CHL	Class II	2013-04-19
K122210	Newfix External Fixation System	Tecnologia Y Diseno Industrial, S.A de C.V	KTT	Class II	2013-04-19
K121804	Provitemp, Dentotemp, Totalcem, Dentocem	Itena Clinical	EMA	Class II	2013-04-19
K130883	Sedecal Digital Radiographic Upgrade Model Sdru-T	Sedecal S.A.	MQB	Class II	2013-04-18
K130772	Md211c2 21.3 Diagnostic Imaging Lcd Monitor	Nec Display Solutions, Ltd.	LLZ	Class II	2013-04-18
K130770	Md211c3 21.3 Diagnostic Imaging Lcd Monitor	Nec Display Solutions, Ltd.	LLZ	Class II	2013-04-18
K130717	Endo Gia Reload	Covidien, Formerly US Surgical A Divison of Tyco H	GDW	Class II	2013-04-18
K130548	Epicage Interbody Fusion Device	Alphatec Spine, Inc.	MAX	Class II	2013-04-18
K130152	Hydrasolve Lipoplasty System	Andrew Technologies, LLC	MUU	Class II	2013-04-18
K130100	Comined Standard Solution	Mesa Laboratories Inc	FKH	Class II	2013-04-18
K124049	Deepview Digital Video Physiological Portable Imaging System	Spectralmd, Inc.	DPT	Class II	2013-04-18
K123900	Suresigns Vm4, Suresigns Vm6, Suresigns Vm8	Philips North America LLC	MHX	Class II	2013-04-18
K123676	Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2013-04-18
K123280	Neoclose Hasson, Neoclose Universal	Neosurgical, Ltd.	GCJ	Class II	2013-04-18
K122461	Rhythmia Mapping Catheter	Rhythmia Medical, Inc.	DRF	Class II	2013-04-18
K122200	A3f Frational	Pollogen Ltd	GEI	Class II	2013-04-18
K122199	Prexion3d Eclipse	The Yoshida Dental Mfg. Co., Ltd.	OAS	Class II	2013-04-18
K121659	Burn Resuscitation Decision Support System (Brdss)	Arcos, Inc.	PDT	Class II	2013-04-18
K130817	Ltn - Laparoscopic Surgical Mesh	LifeCell Corp	OXK	Class II	2013-04-17
K130725	Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5Fr, 3.5Fr, 5 Fr.	Covidien Lp, Formerly Registered AS Kendall	FOS	Class II	2013-04-17
K130535	Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application	Agamatrix	NBW	Class II	2013-04-17
K130007	Sleep Profiler	Advanced Brain Monitoring, Inc.	OLZ	Class II	2013-04-17
K124009	Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed Chemistry Controls Level 2, Mission C	DIAMOND DIAGNOSTICS Inc	JJY	Class I	2013-04-17
K123945	Strive Dual Zone Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	2013-04-17
K123804	Instaflo Bowel Catheter System Kit	Hollister, Inc.	KNT	Class II	2013-04-17
K123597	Truecpr Coaching Device	Physio Control, Inc.	LIX	Class II	2013-04-17
K123593	Quanta Flash Sm, Quanta Flash Rnp, Quanta Flash Sm Calibrators, Quanta Flash Rnp Calibrators, Quanta Flash Sm Controls,	Inova Diagnostics, Inc.	LKP	Class II	2013-04-17
K123467	Vs3	Visionsense, Ltd.	GCJ	Class II	2013-04-17
K123290	M300 & M400	Permobil, AB	ITI	Class II	2013-04-17
K123083	Covidien Warmtouch Convective Warming Unit	Medtronic, Inc.	DWJ	Class II	2013-04-17
K122716	Plasmatrode Saline Safe Tur Electrode	Cook Ireland Ltd.	GEI	Class II	2013-04-17
K121770	Headstar Medical Small Volume Jet Nebulizer	Headstar Medical Products Co., Ltd	CAF	Class II	2013-04-17
K130718	Peerscope System	Peermedical	FDF	Class II	2013-04-16
K130114	Painmaster Mct Patch	Newmark, Inc.	NUH	Class II	2013-04-16
K123045	Brigade Standalone System	NuVasive Inc	OVD	Class II	2013-04-16
K122823	Sign Pediatric Fin Nail	SIGN Fracture Care International	HSB	Class II	2013-04-16
K130673	Lospa Total Knee Replacement System	Corentec Co., Ltd.	JWH	Class II	2013-04-15
K123909	Aesculap Cespace Xp	Aesculap Implant System, Inc.	ODP	Class II	2013-04-15
K123888	Z Cartridge IOL Delivery System	Aaren Scientific Inc.	MSS	Class I	2013-04-15
K123853	Vivasight-Dl System	Etview, Ltd.	CBI	Class II	2013-04-15
K123621	Opticross 40 Mhz Coronary Imaging Catheter	Boston Scientific Corporation	OBJ	Class II	2013-04-15
K123573	Youlaser CO2 Laser	Quanta System Inc.	GEX	Class II	2013-04-15