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 1455 of 3531

510(k) clearances, page 1455 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030113	Monitect Oxycodone Drug Screen Cassette Test, Model Mc 23, Fastect Oxycodone Drug Screen Dipstick Test, Model Md23	Branan Medical Corp.	DJG	Class II	2003-07-02
K024307	Dermosonic Non-Invasive Subdermal Therapy System	Sybaritic, Inc.	IMI	Class II	2003-07-02
K024191	S7 Elite and Autoset Spirit CPAP Systems with Reslink	ResMed Corp	BZD	Class II	2003-07-02
K024080	Secquire Cell Separator	Perfusion Partners & Assoc., Inc.	JQC	Class I	2003-07-02
K023179	Readi-Strand, Model Psstrand	Worldwide Medical Technologies, LLC	KXK	Class II	2003-07-02
K031835	Hl888ra	Health & Life Corporation	DXN	Class II	2003-07-01
K031803	Depuy Ceramic Femoral Heads	Depuy Orthopaedics Inc.	LZO	Class II	2003-07-01
K031783	Safe-Connect Drug Dispensing Spike, Models Sc 4020, Sc 4015, Sc 4010, Sc 4005	Intravascular Incorporated	FPA	Class II	2003-07-01
K031734	Generation 4 Polished Femoral Hip Prosthesis	Zimmer GmbH	JDI	Class II	2003-07-01
K031695	Hl168r	Health & Life Corporation	DXN	Class II	2003-07-01
K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	HWC	Class II	2003-07-01
K031445	Mainline Maxie Hcg Urine Pregnancy Test	Mainline Technology, Inc.	JHI	Class II	2003-07-01
K031441	Urichemtrak Liquid Assayed Urine Control	Medical Analysis Systems, Inc.	JJW	Class I	2003-07-01
K031392	Mas Tox Ammonia Controlliquid Assayed Tox Ammonia Control	Medical Analysis Systems, Inc.	DKC	Class I	2003-07-01
K031033	Given Diagnostic System	Given Imaging Ltd.	NEZ	Class II	2003-07-01
K024169	Macropore Os Reconstruction	Macropore Biosurgery, Inc.	EZX	Class II	2003-07-01
K023668	Jms Extension Set with Planecta, Planecta (Stand Alone Unit), Planecta Lock & Planecta Adaptor	JMS North America Corp.	FPA	Class II	2003-07-01
K031886	Sonoview Pro by Medison Co., Ltd.	Medison Co., Ltd.	LLZ	Class II	2003-06-30
K031884	Interferential Stimulator, Model Netwave	Ryan Telemedicine	IPF	Class II	2003-06-30
K031754	Flexiskin Powder Free Latex Examination Gloves, Non Sterile	Pt. Mandiri Inti Buana	LYY	Class I	2003-06-30
K031540	Apex Electric Handpiece System	Lares Research	EKX	Class I	2003-06-30
K031382	Modification to Hermes o.r. Control Center	Computer Motion, Inc.	GCJ	Class II	2003-06-30
K031141	Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope	asap endoscopic products GmbH	FAJ	Class II	2003-06-30
K030559	Rusch Polyflex Stent for the Esophagus W/introducer/delivery System	Rusch Intl.	ESW	Class II	2003-06-30
K024323	Century Series Holter Scanner System, Models C3000, C2000 and C1000	Biomedical Systems Corp.	MLO	Class II	2003-06-30
K024298	Antimicrobial Alginate Dressing	Advanced Medical Solutions Limited	FRO	Unclassified	2003-06-30
K031888	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	MNI	Class II	2003-06-27
K031655	Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	MNI	Class II	2003-06-27
K031585	U&i, Optima, Spinal System	U&I Corp., America	MNH	Class II	2003-06-27
K031538	Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit	Boston Scientific Corporation	KNT	Class II	2003-06-27
K031522	Solo-Care Plus Multipurpose Solution	Alcon Laboratories	LPN	Class II	2003-06-27
K031521	Aosept Clear Care Cleaning and Disinfecting Solution	Alcon Laboratories	LPN	Class II	2003-06-27
K031486	Blastfreeze and Blastthaw	Medicult A/S	MQL	Class II	2003-06-27
K031423	Ebi P148 Spinal Fixation System	Ebi, LLC	MNH	Class II	2003-06-27
K031302	Sustain Spacer	Globus Medical, Inc.	MQP	Class II	2003-06-27
K031188	Orthomend	Integra LifeSciences Braintree Inc.	FTL	Class II	2003-06-27
K031130	Ya Mei First Aid Kit	Ya Mei Technology Co., Ltd.	KGO	Class I	2003-06-27
K031026	Eti Bipolar Hemostatic Probe	Endo-Therapeutics, Inc.	KNS	Class II	2003-06-27
K031023	Peregrine Illuminating Laser Probe Model Pd600.10	Peregrine Surgical, LLC.	HQF	Class II	2003-06-27
K031014	Hi-Flo Therme Pneu 45, Wisap #7083, 7083V	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HIF	Class II	2003-06-27
K030863	Ebv Vca-P18 Igg Elisa	Panbio Limited	LSE	Class I	2003-06-27
K030838	Wartner Pro	Wartner Medical Products	GEH	Class II	2003-06-27
K030744	Blackstone Surgical Titanium Mesh	Blackstone Medical, Inc.	MQP	Class II	2003-06-27
K030687	K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models Kai-090; Kaj-091C	Kamiya Biomedical Company, LLC	DAP	Class II	2003-06-27
K030682	Calcium Hydroxylapatite Implant, Icc and 0.5Cc, Models 8038-3, 8037-3	Bioform, Inc.	LYC	Class II	2003-06-27
K030605	Rapid Imf	Zygomatics, Ltd.	DYX	Class II	2003-06-27
K023378	Oria Claris	Ortho Tec, LLC	MNH	Class II	2003-06-27
K021979	Smisson Stabilization System	Smisson-Cartledge	KWQ	Class II	2003-06-27
K031766	Atb All-Terrain Balloon Pta Dilatation Catheter	Cook Inc.	DQY	Class II	2003-06-26
K031751	Rapidfire Self Drilling Screws	Biomet Microfixation	HWC	Class II	2003-06-26