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 2026-11-05, 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 1704 of 3531

510(k) clearances, page 1704 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K993926	Omniaxial Connector	Ortho Tec, LLC	MNH	Class II	1999-12-17
K993443	Rtd Arm Assistive Robotic Device	Rehabilitation Technologies Division	ITI	Class II	1999-12-17
K993202	Eim-107 Prep-Check	General Devices	GZO	Class II	1999-12-17
K993157	Hem-O-Lok Smx Polymer Clips, Model 544220, Hem-0-Lok Mlx Polymer Clips, Model 544240	Weck Closure Systems	FZP	Class II	1999-12-17
K993153	Intralase 600C Laser Keratome	Intra Lase Corp.	GEX	Class II	1999-12-17
K993139	Yp 45/15-Bp; Yp 53/15-Bp; Yp 60/15-Bp	BIOTRONIK AG	DTB	Class III	1999-12-17
K993130	Ultra-Garment Electrode	Newwave Medical, LLC	GXY	Class II	1999-12-17
K993123	Qk-Wide Band Spectrum Therapeutic Apparatus, Models Co1a, Co1b, Co1c, Co1d, Co2a, Co2b	united pacific Company	ILY	Class II	1999-12-17
K993118	Bioteque A.v. Fistula Needle Set	Bioteque Corp.	FIE	Class II	1999-12-17
K993115	Multitak Ss	Bonutti Research, Inc.	MAI	Class II	1999-12-17
K994093	At Work Drug Test, Model 9145-25C; Model 9177-25C	Phamatech Inc.	LCL	Unclassified	1999-12-16
K993952	Immulite 2000 Cmv Igg, Model L2kcv2, L2kcv6	Siemens Healthcare Diagnostics Inc.	LFZ	Class II	1999-12-16
K993837	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	CGA	Class II	1999-12-16
K993835	Parapost System Sterilizable Organizer	Coltene /Whaledent AG	FRG	Class II	1999-12-16
K993764	Medipack See-Through Seal Sterilization Pouch	Medipack Medical Packaging Mfg. Co.	KCT	Class II	1999-12-16
K993711	Additional Ims Assays for the Bayer Advia Ims System (Invitro Diagnostic System with 5 Additional Assays)	Bayer Corp.	JZG	Class II	1999-12-16
K993571	Bayer Diagnostics Acs:180 Vb12, Bayer Diagnostics Advia Centaue Vb12	Bayer Corp.	CDD	Class II	1999-12-16
K993468	Wako L-Type Got Test	FUJIFILM Healthcare Americas Corporation	CIT	Class II	1999-12-16
K993379	Pall Supor Aef Filter	Pall Corp.	FPB	Class II	1999-12-16
K993333	Clearplan Easy II Home Pregnancy Test	Unipath, Ltd.	LCX	Class II	1999-12-16
K993327	Talon Anchor Snap-Pak	Mitek Products	DZL	Class II	1999-12-16
K993033	Intray Gc	Biomed Diagnostics, Inc.	JTY	Class II	1999-12-16
K992681	Patient Latex Examination Glove Powdered & Powder Free, Sterile	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	1999-12-16
K992676	Patient Latex Examination Powder-Free Polymer Coated Gloves	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	1999-12-16
K992626	Sure-Way Reusable Sharps Container	Sure-Way Systems, Inc.	FMI	Class II	1999-12-16
K992552	Copalis Treponemal Antigen Total Antibody Assay	Diasorin Inc.	LIP	Class II	1999-12-16
K992111	Verdict -II Opiates 2000	MEDTOX Diagnostics, Inc.	DJG	Class II	1999-12-16
K991246	Fructosamine, Model Fr 106-01	A.P. Total Care, Inc.	LCP	Class II	1999-12-16
K993855	Atlantis Anterior Cervical Plate System	Danek Medical, Inc.	KWQ	Class II	1999-12-15
K993689	AED Cystoscope	National Advanced Endoscopy Devices, Inc.	FAJ	Class II	1999-12-15
K993628	Omnisonics Ultrasonic Probes	Omnisonics Medical Technologies	LFL	Unclassified	1999-12-15
K993602	Pre-Vision Fill	Kulzer GmbH	EBF	Class II	1999-12-15
K993597	Plll, Teleradpro, Model 12714/12715, Vxr-12 Plus, Model 8619/9617	Vidar Systems Corp.	LMA	Class II	1999-12-15
K993594	Conformax Mmlc Vr1	Radionics, Inc.	IYE	Class II	1999-12-15
K993539	Dci Endoscope	Karl Storz Endoscopy-America, Inc.	GWG	Class II	1999-12-15
K993532	Dds, Ds3000, Rs3000, Cs5000, Ot3000, Is3000, Rs5000, Cd3000, Us3000, (Amongst Other Names)	Impax Technology, Inc.	LLZ	Class II	1999-12-15
K993530	System 2100	Math Solutions, LLC	LLZ	Class II	1999-12-15
K993423	Bact/alert Sa	bioMerieux, Inc.	MDB	Class I	1999-12-15
K993413	Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control	Invacare GmbH	ITI	Class II	1999-12-15
K993296	Trip Tonometry Catheter, 14F	GE Healthcare	KNT	Class II	1999-12-15
K993099	Bremer Halo System Titanium Skull Pin	Depuyacromed	JEC	Class II	1999-12-15
K992631	Acunav Diagnostic Ultrasound Catheter	Acuson Corp.	DQO	Class II	1999-12-15
K991401	Atr 3000, Atr 2000, Implant-Pro	Advanced Technology Research (A.T.R.) S.R.P.	EFB	Class I	1999-12-15
K990058	Qms Mapping System,model 2000	Cathdata, Inc.	DQK	Class II	1999-12-15
K993886	Ebi Xfix Vision Fixation System	Ebi, LLC	KTT	Class II	1999-12-14
K993576	Bact/alert Mp Process Bottle	bioMerieux, Inc.	MDB	Class I	1999-12-14
K993421	Bact/alert Sn	bioMerieux, Inc.	MDB	Class I	1999-12-14
K993276	Simplify D-Dimer, Model Dcgk1	Agen Biomedical, Ltd.	GHH	Class II	1999-12-14
K993783	Tetric Flow	Ivoclar North America, Inc.	EBF	Class II	1999-12-13
K993683	Pulpdent Uno-Duo	Pulpdent Corporation	KLE	Class II	1999-12-13