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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1718 of 3533

510(k) clearances, page 1718 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992899	Bio-Modular Shoulder Offset Humeral Heads	Zimmer GmbH	KWS	Class II	1999-10-21
K992898	The Bright Medical Dilation Retractor System	Bright Medical Instruments	GZT	Class II	1999-10-21
K992679	Surgeon Powder-Free Gloves, Latex, Sterile	Wear Safe (Malaysia) Sdn Bhd	KGO	Class I	1999-10-21
K992582	Pacific Implant Titanium Endodontic Point	Pacific Implant, Inc.	EKL	Class I	1999-10-21
K991897	Catheter Innovations Implantable Port	Catheter Innovations, Inc.	LJT	Class II	1999-10-21
K991556	Zoll M Series 12Sl Analysis Option	ZOLL Medical Corporation	MKJ	Class III	1999-10-21
K993165	Quickscreen Pro Multi Drug Screen, Model 9177 & 9178	Phamatech Inc.	DJG	Class II	1999-10-20
K993138	Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit	Ballard Medical Products	KNT	Class II	1999-10-20
K993080	Ambiderm Latex Examination Gloves (Violet, Blue , Green, and Pink) Containing 50 Mcgm or Less of Total Water Extractable	Medtexx Partners, Inc.	LYY	Class I	1999-10-20
K992468	Braun Thermoscan Pro3000 Infared Thermometer	Braun AG	FLL	Class II	1999-10-20
K992447	50 W Metal Halide Illuminator, Ves 0501.	Angiolaz, Inc.	FCW	Class II	1999-10-20
K991280	125 Implant Seeds, Model Stm1251	Sourcetech Medical, LLC	KXK	Class II	1999-10-20
K991132	Activa	Hoveround Corp.	INI	Class II	1999-10-20
K991014	Case 8000 Exercise Testing System	General Electric Medical Systems Information Techn	LOS		1999-10-20
K990787	Trio 300	Ito Co., Ltd.	IPF	Class II	1999-10-20
K992880	P.a.s. Port Elite Implantable Venous Access System	Sims Deltec, Inc.	LJT	Class II	1999-10-19
K992707	Mcl 29 Dermablate Er:yag Laser System	Aesculap-Meditec North America	GEX	Class II	1999-10-19
K992647	Pasco Mic and Mic/id Panels, Erythromycin	Pasco Laboratories, Inc.	JTN	Class II	1999-10-19
K992646	Pasco Mic and Mic/id Panels, Penicillin	Pasco Laboratories, Inc.	JTN	Class II	1999-10-19
K992425	Tes-20	Tes Electrical Electronic Corp.	MWJ	Class II	1999-10-19
K990141	Light Diagnostics Simulfluor Hsv/vzv Immunoflourescence Assay, Model 3295	Light Diagnostics	GQW	Class II	1999-10-19
K993178	Urea-L3k Assay, Catalogue Number 283-17/10/30/50	Sekisui Diagnostics P.E.I. Inc.	CDQ	Class II	1999-10-18
K992971	Rep Cholesterol Profile Kit	Helena Laboratories, Corp.	JHO	Class I	1999-10-18
K992846	Hichem Total Protein Reagent	Elan Holdings, Inc.	CEK	Class II	1999-10-18
K992845	Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration Standards Kit	Elan Holdings, Inc.	JIX	Class II	1999-10-18
K992766	N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set	Genzyme Corporation	MRR	Class I	1999-10-18
K992723	Orthopedic Perioperative Autotransfusion (Orthopat) System	Transfusion Technologies Corp.	CAC	Class II	1999-10-18
K992695	Insure Pro Test	Inbios Intl., Inc.	JHI	Class II	1999-10-18
K992692	Extreme H20 (Hioxifilicon a) Soft Contact Lens	Benz Research and Development LLC	LPL	Class II	1999-10-18
K992580	Fetal Assessment Cap	Acuson Corp.	IYO	Class II	1999-10-18
K992533	Philips Gyroscan Intera (*)	Philips North America LLC	LNH	Class II	1999-10-18
K992523	Health-Plus Sanitex,reliance Pre-Powdered Multi-Ply Latex Examination Glove (Natural Rubber Latex-Nitrile-Construction W	Pamitex Industries Sdn Bhd	LYY	Class I	1999-10-18
K992452	Rapidone-Amphetamine Test	American Bio Medica Corp.	DOD	Class II	1999-10-18
K991926	Opap	Opap, Inc.	BZD	Class II	1999-10-18
K991239	Vip 60 (2H), Model 115-000-1, Vip 60 (4H), Model 115-000-2	Micron Corp.	ELC	Class II	1999-10-18
K990752	Dermagrip Powder Free Nitrile Examination Glove, Non Sterile	Wrp Specialty Products Sdn. Bhd.	LZA	Class I	1999-10-18
K993279	Qsc-085 Shoulder Array Coil	Mri Devices Corp.	MOS	Class II	1999-10-15
K993235	Qwh-085 Wrist Array Coil	Mri Devices Corp.	MOS	Class II	1999-10-15
K993233	Obc-085 Breast Array Coil	Mri Devices Corp.	MOS	Class II	1999-10-15
K993148	Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga	Stryker Corp.	FYA	Class II	1999-10-15
K992878	Anti-Tissue Transglutaminase (Ttg)antibody Test	Immco Diagnostics, Inc.	MVM	Class II	1999-10-15
K992870	Polymer Coated Powder Free Latex Examination Gloves Labeling Content: 100 Mcgm or Less of Total Water Extractable Protei	Alliance Rubber Products Sdn. Bhd.	LYY	Class I	1999-10-15
K992816	Modification to Intrastent	Intratherapeutics, Inc.	FGE	Class II	1999-10-15
K992591	Codman Single and Double Lumen Skull Bolt Kits	Cerenovus, Inc.	GWM	Class II	1999-10-15
K992511	Abx Pentra 60 Hematology Analyzer	Horiba Instruments Incorporated	GKZ	Class II	1999-10-15
K992478	Physiological Signal Transmitter and Receiver, Model 3810A	Hewlett-Packard, Healthcare Solutions Group	DXN	Class II	1999-10-15
K992469	Ksea Scbcom	Karl Storz Endoscopy-America, Inc.	FET	Class II	1999-10-15
K992435	Bacti-Stop Toothbrush Cleaner and Sanitizer	Azo Enterprises	EFW	Class I	1999-10-15
K992416	Perioglas- Bioglass Bone Graft Particulate	Usbiomaterials Corp.	LYC	Class II	1999-10-15
K992410	Actitrac	Individual Monitoring Systems, Inc.	GWQ	Class II	1999-10-15