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 1045 of 3531

510(k) clearances, page 1045 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K092214	Chiropro L System	Bien-Air Dental SA	EBW	Class I	2009-12-15
K091996	Orthocor Knee System Basic	Orthocor Medical Inc.	ILX	Class II	2009-12-15
K091675	Laserpen Practise and Expert, Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser	Reimers and Janssen GmbH	ILY	Class II	2009-12-15
K091462	Spectra Medical Safety Scapel	Spectra, Inc.	GDZ	Class I	2009-12-15
K091301	Life Spine Stand-Alone Spacer System	Life Spine	OVD	Class II	2009-12-15
K090931	Cordless Endo Handpieces Eb-300, Entran and Eb-300 S, S5 Endo Motor	W & H DentalWerk Buermoos GmbH	EKX	Class I	2009-12-15
K090785	MRI Compatible Patient Monitoring System, Model 865214	Invivo Corporation	MWI	Class II	2009-12-15
K090598	Cariescan Pro	Cariescan, Ltd.	NBL	Class II	2009-12-15
K093498	Liaison N-Tact Pth Calibration Verifiers Model 310913	Diasorin Inc.	JJX	Class I	2009-12-14
K092663	Eli 350 Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2009-12-14
K090940	Spotcheck Blood Spot Control, Assayed	Astoria-Pacific, Inc.	JJT	Class I	2009-12-14
K093691	Accumax	Boston Scientific Corporation	GEX	Class II	2009-12-11
K093672	Aegis Navigation Anda Egis Pelvic Application	Sentinelle Medical, Inc.	LLZ	Class II	2009-12-11
K093642	Neutrasal	Invado Pharmaceuticals	LFD	Unclassified	2009-12-11
K093117	Digital Lightbox	Brainlab, Inc.	LLZ	Class II	2009-12-11
K092964	Cooltouch Varia Nd:yag Laser System	New Star Lasers, Inc.	GEX	Class II	2009-12-11
K092943	Aspirating Syringe, Non-Aspirating Syringe	Arnold Tuber Industries	EJI	Class II	2009-12-11
K092682	Gyrus Acmi Flexible Endoscope Storage-Sterilization Trays	Gyrus ACMI, Inc.	KCT	Class II	2009-12-11
K092647	Lensx 550 Laser System	Lensx Lasers, Inc.	OOE	Class II	2009-12-11
K092505	Beckman Coulter Ferritin Reagent, Model: Osr61203	Siemens Healthcare Diagnostics Inc.	DBF	Class II	2009-12-11
K092417	Insight Ultrasonic Inserts	Discus Dental LLC	ELC	Class II	2009-12-11
K091711	S- Test Hemoglobin Alc (Hba1c), Model Rc0023	Alfa Wassermann Diagnostic Technologies, Inc.	LCP	Class II	2009-12-11
K091364	Dicompacs, Model 5.2, Dicompacs Dx-R, Model 1.4	Oehm und Rehbein GmbH	LLZ	Class II	2009-12-11
K091331	Piezotome 2	Satelec	DZI	Class II	2009-12-11
K091233	Synthes Matrixmandible Subcondylar Plates	Synthes (USA) Products LLC	JEY	Class II	2009-12-11
K083845	Xtag Cf60 Kit V2	Luminex Molecular Diagnostics Inc	NUA	Class II	2009-12-11
K082588	Gammaloc System, Model 03-00001	Dilon Technologies Inc	IYX	Class I	2009-12-11
K081092	Modification to Mammaprint	Agendia Inc	NYI	Class II	2009-12-11
K093714	Sonoace X8 Diagnostic Ultrasound System	Medison Co., Ltd.	ITX	Class II	2009-12-10
K093525	Ace/statcheck II CO2 Indicator, Ace/statcheck II CO2 Indicator Arm Assemby Adult Statcheck Resuscitator with Ace/statche	Salter Labs	CCK	Class II	2009-12-10
K093514	Discovery Model Nm/ct 670	GE Medical Systems F.I. Haifa	KPS	Class II	2009-12-10
K093285	Modification to Lanx Spinal Fixation System	Lanx, Inc.	MNI	Class II	2009-12-10
K093227	Silverstream and Dermasept	Enzysurge, Ltd.	FRO	Unclassified	2009-12-10
K092807	Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103	Augustine Biomedical & Design, LLC	DWJ	Class II	2009-12-10
K092744	Neonatal ECG Electrode, M203ken	R & D Medical Products, Inc.	DRX	Class II	2009-12-10
K092644	Terumo Pressure Isolator	Terumo Cardiovascular Systems Corporation	DRS	Class II	2009-12-10
K092596	Eagle Eye Platinum Digital Ivus Catheter	Volcano Corporation	OBJ	Class II	2009-12-10
K092125	Presidio Pacs	Reaonix Security, LLC	LLZ	Class II	2009-12-10
K092099	No-Coding Blood Glucose Monitoring System, Models Td-4251, Td-4252, Td-4253 and Td-4254	Taidoc Technology Corporation	NBW	Class II	2009-12-10
K092002	Afghan External Fixator	Smith & Nephew, Inc.	KTT	Class II	2009-12-10
K090794	Osteotape	Impladent, Ltd.	NPM	Class II	2009-12-10
K093750	Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow Hpc Flow Directed Micro Catheter, Reba	Ev3, Inc.	KRA	Class II	2009-12-09
K093332	Delphi Infusion Pump/ Delphi Administration Set Model IV-01000/ Model IV-02Xxxx (Where X Is Any Number Between 0-9)	Delphi Medical Systems	FRN	Class II	2009-12-09
K092914	Wedgeloc 180X (Standard) and (Cortical) Suture Anchor with Opti-Fiber Sutures	Medshape, Inc.	MBI	Class II	2009-12-09
K091992	Eidosmed, Model Edg4.0	Eidosmed, LLC	OOL	Class II	2009-12-09
K091884	Ark Zonisamide Assay, Ark Zonisamide Calibrator, and Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003	Ark Diagnostics Inc	NWM	Class II	2009-12-09
K093312	Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access Dilation System	Kimberly-Clark Corporation	KGC	Class II	2009-12-08
K093052	Crosscath Support Cathter	Cook Inc.	KRA	Class II	2009-12-08
K092966	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Jin Zhou Chang Hao Plastic Products Co., Ltd.	LYZ	Class I	2009-12-08
K092032	Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	2009-12-08