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 1396 of 3531

510(k) clearances, page 1396 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K040646	Straumann Granules	Straumann USA, LLC	LYC	Class II	2004-05-03
K040514	Eovia Calcium Phosphate Ceramic	Ortho Tec, LLC	MQV	Class II	2004-05-03
K040427	Fibrex Catheter Patency Device	Medical Device Technologies, Inc.	FOZ	Class II	2004-05-03
K040312	Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus	Procter & Gamble Co.	HIL	Class II	2004-05-03
K040274	Acon Opi One Step Opiate Test Strip and Acon Opi One Step Opiate Test Device	Acon Laboratories, Inc.	DJG	Class II	2004-05-03
K040968	Wu's 4-Wheeled Neo Scooter, Model Wt-T4d	Wu's Tech Co., Ltd.	INI	Class II	2004-04-30
K040899	Medex 3000 Series Mr Syringe Infusion Pump	Medex, Inc.	FRN	Class II	2004-04-30
K040867	Perivac Kit, Models 4304, 4305, 4314, 4315	Boston Scientific Corporation	DQX	Class II	2004-04-30
K040843	Hemosil Von Willebrand Activity	Instrumentation Laboratory Co.	GGP	Class II	2004-04-30
K040842	Senorx Biopsy Device II	Senorx, Inc.	KNW	Class II	2004-04-30
K040827	Panalok Loop Anchor	DePuy Mitek, Inc.	MAI	Class II	2004-04-30
K040761	Axsym Cyclosporine	Abbott Medical	MKW	Class II	2004-04-30
K040738	Mobile Oxygen Storage Tank (Most)	Pacific Consolidated Industries LLC	CAW	Class II	2004-04-30
K040469	The Straumann Ortho Implant System	Straumann USA, LLC	OAT	Class II	2004-04-30
K040393	Riva Luting	Southern Dental Industries, Inc.	EMA	Class II	2004-04-30
K040289	Smartlite D Frequency Doubled Nd:yag Laser	Cynosure, LLC	GEX	Class II	2004-04-30
K040276	Quantum Cement Restrictor	Quantum Orthopedics, Inc.	JDK	Class II	2004-04-30
K040161	Sona Pillow	Sleep Devices, Inc.	MYB	Class II	2004-04-30
K033198	Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2	Apoza Enterprise Co., Ltd.	ELC	Class II	2004-04-30
K033077	Easytem Duo, Forehead/ear Thermometer, Model Bt-021	Metatech Corp.	FLL	Class II	2004-04-30
K031687	Vanguard Reprocessed External Fixation Devices	Stryker Sustainability Solutions	KTT	Class II	2004-04-30
K030604	Perfect Safety Syringe	Perfect Medical Industry Co., Ltd.	MEG	Class II	2004-04-30
K040998	Modification to Parietex Composite (Pco) Mesh	Sofradim Production	FTL	Class II	2004-04-29
K040917	Philips Anesthesia Gas Monitor, Model M1026b	Philips Medizin Systeme Boeblingen GmbH	CBQ	Class II	2004-04-29
K040892	Mark 5 Nuvo Ocsi (M5c5), Models 505 and 905	Nidek Medical Products Inc	CAW	Class II	2004-04-29
K040833	Modification to Ebi Xfix Vision Fixation System	Ebi, LLC	KTT	Class II	2004-04-29
K040824	Interferential Stimulator, Model Bmls03-6	BioMedical Life Systems Inc.	LIH	Class II	2004-04-29
K040803	Ms-30 Femoral Stem Standard and Lateral	Zimmer GmbH	LZO	Class II	2004-04-29
K040776	Atlantis Sr, Model C4020; Atlantis Sr Plus, Model 35975	Boston Scientific Corporation	DQO	Class II	2004-04-29
K040690	Surgifrost 10 Cm Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console	Medtronic CryoCath LP	OCL	Class II	2004-04-29
K040540	Modification to Ltv 1000 Ventilator	Pulmonetic Systems, Inc.	CBK	Class II	2004-04-29
K040282	Atramat and Sorb-Fast Polyglycolic Acid	Internacional Farmaceutica, S.A. de C.V.	GAM	Class II	2004-04-29
K040228	Medi-Stim Veriq System, Model Vq1001 - Vq4122	Medi-Stim, Inc.	DPW	Class II	2004-04-29
K040008	Quickvue Advance Ph and Amines Gll Test	Ortho-Clinical Diagnostics, Inc.	CEN	Class I	2004-04-29
K033755	Minray	Soredex Palodex Group Oy	EHD	Class II	2004-04-29
K033453	Kendall Ultec Pro Ag+ Hydrocolloid Dressing	Tyco Healthcare	FRO	Unclassified	2004-04-29
K032568	Bp Cuff Barrier 1081789, Bp Cuff Barrier, Plastic Coated 1030193	Med Textile, LLC	DXQ	Class II	2004-04-29
K022688	Versabond Ab Bone Cement	Smith & Nephew, Inc.	LOD	Class II	2004-04-29
K040989	Rita Systems	Boston Scientific Corporation	GEI	Class II	2004-04-28
K040925	Normal and Hypergamma Control Serum	Sebia	JJY	Class I	2004-04-28
K040880	Mas Cardioimmune Tl Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3	Medical Analysis Systems, Inc.	JJY	Class I	2004-04-28
K040808	Mini l.e.d. Oem Module	Satelec	EBZ	Class II	2004-04-28
K040804	.Decimal Tissue Compensator/intensity Modulator	Southeastern Radiation Products, Inc.	IXI	Class II	2004-04-28
K040802	Hemosonic 200Hemodynamic Monitor	Arrow Intl., Inc.	DPN	Class II	2004-04-28
K040785	Concerto Bipolar Needle Electrode	Boston Scientific Corporation	GEI	Class II	2004-04-28
K040709	Protos Software	Aktina Medical Physics Corp.	IYE	Class II	2004-04-28
K040653	Paramount Mini Gps Biliary Stent System	Medtronic, Inc.	FGE	Class II	2004-04-28
K040645	Dermagrip-G, and Multiple Customers Trade Name Green, Aloe Vera Coated, Powder Free Latex Examination Gloves with Protei	WRP Asia Pacific Sdn Bhd	LYY	Class I	2004-04-28
K040573	Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236	Nobel Biocare Uas, Inc.	NHA	Class II	2004-04-28
K040470	Tripter X-1 Compact	Direx Systems Corp.	LNS	Class II	2004-04-28