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 898 of 3530

510(k) clearances, page 898 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K111575	Hemasorb Absorbable Bone Hemostat Matrix	Orthocon, Inc.	MTJ	Unclassified	2012-05-23
K111476	Contour Technology Muscle Stimulator	Contour Technology	NGX	Class II	2012-05-23
K111262	Electrosurgical Monopolar Cable/adapters, Electrosurgical Bipolar Cable/ Adapters, Bipolar Electrosurgical Cables, Monop	Olsen Medical	GEI	Class II	2012-05-23
K110632	Lucent or Lucent Magnum	Spinal Elements, Inc	MAX	Class II	2012-05-23
K121265	Amphirion Plus Pta Catheter	Medtronic, Inc.	LIT	Class II	2012-05-22
K121263	Taper Set Hip System Rdp Stem	Consensus Orthopedics, Inc.	LPH	Class II	2012-05-22
K120586	Cell Saver Elite	Haemonetics Corporation	CAC	Class II	2012-05-22
K120533	Bigboss Catheters Mantatay Catheter Mantaray Guidewires	Boston Scientific Corporation	PDU	Class II	2012-05-22
K120443	Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device	Baxter Healthcare Corporation - Renal Division	FPA	Class II	2012-05-22
K120042	Td-4268 Blood Glucose Monitoring System Td-4268 Multi Blood Glucose Monitoring System	Taidoc Technology Corporation	LFR	Class II	2012-05-22
K120013	Tempspan Clear Matrix	Pentron Clinical	ELW	Class II	2012-05-22
K113103	Splitwire Percutaneous Transluminal Angioplasty Scoring Device	Rex Medical LP	PNO	Class II	2012-05-22
K112881	Nexstim Navigated Brain Stimulation (Nbs) System 4, Nexstim Nbs System 4 with Nexspeech(tm)	Nexstim Inc.	GWF	Class II	2012-05-22
K112527	Universal Digital Interface (UDI) 1717	Meridian Medical Systems, LLC	MQB	Class II	2012-05-22
K111862	Viewray System	Viewray Systems, Inc.	IYE	Class II	2012-05-22
K120619	Orthodontic Flowable Bracket Adhesive	Novocol, Inc.	DYH	Class II	2012-05-21
K120495	Impulse and Expo Angiographic Catheter	Boston Scientific Corporation	DQO	Class II	2012-05-21
K120419	Dyna Locking Ankle Nail	CG MedTech Co., Ltd.	HSB	Class II	2012-05-21
K120404	Merz Dental Gmbh Artegral Hd Preformed Plastic Denture Teeth	Merz Dental GmbH	ELM	Class II	2012-05-21
K120130	Faller Trocar	Medigroup	FJS	Class II	2012-05-21
K120104	Visionsearch 1	Visionsearch Pty, Ltd.	GWE	Class II	2012-05-21
K121237	Beta Hcg Control Level 1 Beta Hcg Control Level 2 Beta Hcg Control Level 3 Beta Hcg Calibration Verification Controls Le	Cliniqa Corporation	JJX	Class I	2012-05-18
K121207	Easymax Mu Self Monitoring Blood Glucose System, Easymax Mu Pro Self Monitoring Blood Glucose System	Eps Bio Technology Corp.	LFR	Class II	2012-05-18
K121143	Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)	Bio-Rad Laboratories Inc.	DIF	Class I	2012-05-18
K120928	Synthes Matrix System	Synthes GmbH	NKB	Class II	2012-05-18
K120911	Xpert Flu Genexpert Dx Systems (Gx-I, Gx-IV)	Cepheid	OQW	Class II	2012-05-18
K120698	Genesis II Ps Non-Modular Femoral Component	Smith & Nephew, Inc.	JWH	Class II	2012-05-18
K120605	Permacol Surgical Implant	Medtronic, Inc.	FTM	Class II	2012-05-18
K120299	Srs Endoscopic Stapling System	Medigus, Ltd.	ODE	Class II	2012-05-18
K120099	Range Spinal System (Mesa and Denali)	K2M, Inc	MNI	Class II	2012-05-18
K120091	R&d Innovation Pedicle Screw System	R&D Innovation, LLC	NKB	Class II	2012-05-18
K113622	Orion II CT Cvc	Health Line International Corporation (Hlic)	FOZ	Class II	2012-05-18
K113576	Double Lumen Video Tracheosdope (Dlvt) System	Etview, Ltd.	CBI	Class II	2012-05-18
K113565	Multi-Med Central Venous Catheters (Cvcs), with and without Heparin Vantex Central Venous Catheters (Cvcs), with Heparin	Edwards Lifesciences LLC	FOZ	Class II	2012-05-18
K113271	Metal-on-Metal Hip Systems-Additional Contraindications	Biomet Manufacturing Corp	KWA	Class III	2012-05-18
K112698	Concentric Balloon Google	United States Endoscopy Group, Inc.	ODC	Class II	2012-05-18
K112457	Leforte System Bone Plate & Screw	Arkin Consulting Group	JEY	Class II	2012-05-18
K111450	Mirocam Capsule Endoscope System	IntroMedic Co., Ltd.	NEZ	Class II	2012-05-18
K121339	Chemtrue Single/multi-Panel Drug Screen Dip Card/cassette Tests	Chemtron Biotech, Inc.	DKZ	Class II	2012-05-17
K121314	Architect B12	Abbott Medical	CDD	Class II	2012-05-17
K121174	Xpress Multi-Sinus Dilation Tool	Entellus Medical, Inc.	LRC	Class I	2012-05-17
K121138	Acuson S3000 Diagnostic Ultrasound System	Siemens Medical Solution	IYN	Class II	2012-05-17
K121009	Heartcheck ECG Pen with Gems Home	Cardiocomm Solutions, Inc.	DPS	Class II	2012-05-17
K120894	Haymax	Haymax Limited	NUP	Class II	2012-05-17
K120729	Haronis Ace Laparoscopic 5Mm Diameter Shears 36Cm Length +Adaptive Tissue Technology Harmonic Ace 5Mm Diameter Shears 23	Ethicon Endo-Surgery Inc	LFL	Unclassified	2012-05-17
K120516	Long Life Padtm	Omron Healthcare Co., Ltd.	GXY	Class II	2012-05-17
K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	HWC	Class II	2012-05-17
K120489	Tissue of Origin Test Kit Ffpe	Pathwork Diagnostics, Inc.	OIW	Class II	2012-05-17
K120440	Presto Breast Biopsy Device	Sontina Medical, LLC	KNW	Class II	2012-05-17
K120059	Liquid Bandage	Chesson Laboratory Associates, Inc.	KMF	Class I	2012-05-17