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 1748 of 3531

510(k) clearances, page 1748 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991363	30 Pump, Continuous Low Flow, 200 Pump, Intermittent with Kvo or Continuous, Pca Pump, Pain Management, Pcea Pump, Epidu	Sorenson Medical, Inc.	FRN	Class II	1999-05-13
K991278	Philips Tomoscan Av-Nt	Philips North America LLC	JAK	Class II	1999-05-13
K991258	Novus Verdi Delivery Systems	Lumenis Ltd	GEX	Class II	1999-05-13
K991129	Hitachi Spectradigital V250dsp Gamma Camera System with Thick Nal(ti) Crystal	Hitachi Medical Corp. of America	KPS	Class II	1999-05-13
K991096	Immulite 2000 Anti-Tpo Ab, Model L2kt02, L2kt06	Siemens Healthcare Diagnostics Inc.	JZO	Class II	1999-05-13
K991094	Immulite 2000 Anti-Tg Ab, Model L2ktg2, L2ktg6	Siemens Healthcare Diagnostics Inc.	JZO	Class II	1999-05-13
K990729	Famous Physicians Brand Disposable Acupuncture Needles	Acc Intl.	MQX	Class II	1999-05-13
K990698	Omni Touch Nitrile Examination Glove, Powdered Purple	Omnigrace (Thailand), Ltd.	LZA	Class I	1999-05-13
K990696	Omni Flex Nitrile Examination Glove, Powder-Free,white	Omnigrace (Thailand), Ltd.	LZA	Class I	1999-05-13
K990515	Mathis Vertebral and Bone Biopsy System	International Medical Systems	KNW	Class II	1999-05-13
K990482	3M Clinpro Prophy Paste, Model 12611	Minnesota Mining and Mfg. Co.	EJR	Class I	1999-05-13
K990479	Hygeniclear Wkr 1, Water-Delivery Device Ultraclear	Hygenitek, Inc.	EIA	Class I	1999-05-13
K990087	Dmd Digital X-Ray System	Dental/Medical Diagnostic Systems, Inc.	MUH	Class II	1999-05-13
K984486	Pulsemaster Dental Laser System	American Dental Technologies, Inc.	GEX	Class II	1999-05-13
K984104	Iti Dental Implant System	Straumann USA, LLC	DZE	Class II	1999-05-13
K983728	Lorenz Imf Screw	Biomet Microfixation	DZL	Class II	1999-05-13
K983575	Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-Xx	Datascope Corp.	DXN	Class II	1999-05-13
K982226	Uromed Brachytheraphy Iodine-125 Sources	Uromed Corp.	KXK	Class II	1999-05-13
K990455	Philips Easy Vision Family Workstation Legs Option	Philips North America LLC	LLZ	Class II	1999-05-12
K990447	1000 Pressure Infusion Sigmacon 1000	Valley West, Inc.	FRN	Class II	1999-05-12
K990441	Insight Sphincter of Oddi Manometry Module, Model S981300	Diversatek Healthcare Inc	FFX	Class II	1999-05-12
K990426	Calcium Scoring	Siemens Medical Solutions USA, Inc.	JAK	Class II	1999-05-12
K984241	Rocs Ultraseed	Radiation Oncology Computer Systems	IYE	Class II	1999-05-12
K991252	Aia-Pack Ft3 Assay	Tosoh Medics, Inc.	CDP	Class II	1999-05-11
K991210	K-Assay Crp Calibrator Set	Kamiya Biomedical Company, LLC	DCK	Class II	1999-05-11
K991136	B-2-Microglobulin Immunological Test System	OLYMPUS Corporation of the Americas	JZG	Class II	1999-05-11
K991070	Coulter Z2 Analyzer	Coulter Corp.	GKL	Class II	1999-05-11
K990957	Astoria-Pacific Spotcheck G6pd Kit 50 Hr, Model 80-3000-13K	Astoria-Pacific, Inc.	JBL	Class II	1999-05-11
K990774	Abbott Architect Cea	Abbott Medical	DHX	Class II	1999-05-11
K990550	3.0T Signa Vh/i Magnetic Resonance System	GE Healthcare	LNH	Class II	1999-05-11
K990442	Advanced Diagnostic Viewer (Aox), Model Vitred 1.3	Canon Medical Informatics, Inc.	LLZ	Class II	1999-05-11
K990411	Mvm 7.5 French Flexible Hysteroscope	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1999-05-11
K990093	Zymed Telemetry System: Model Easiview	Agilent Technologies, Inc.	DSI	Class II	1999-05-11
K990073	Calcitonin	Kmi Diagnostics, Inc.	JKR	Class II	1999-05-11
K990011	Continental 45 Toric Soft (Hydrophilic) Contact Lenses for Daily Wear	Continental Soft Lens, Inc.	LPL	Class II	1999-05-11
K984269	Dbest Occult Blood Test Kit	Ameritek, Inc.	KHE	Class II	1999-05-11
K972803	Tracer O-T-W Mapping Device	Cardima, Inc.	DRF	Class II	1999-05-11
K991369	Accudip Home Pregnancy And/or Aimstick Pregnancy	Germaine Laboratories, Inc.	LCX	Class II	1999-05-10
K991075	Atlast Glucose Control Solution	Amira Medical, Inc.	JJX	Class I	1999-05-10
K990741	Sas One-Step Pregnancy	SA Scientific, Ltd	JHI	Class II	1999-05-10
K990684	Modification of Sas Serum/urine Hcg	SA Scientific, Ltd	JHI	Class II	1999-05-10
K990671	Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument Wipe	Hurricane Medical	HOZ	Class II	1999-05-10
K990480	Opti-Free Supraclens Daily Protein Remover	Alcon Laboratories	LPN	Class II	1999-05-10
K984098	Adventure Tints, Color Enhanced Tinted Soft Contact Lens	Adventures in Color Technology, Ltd.	LPL	Class II	1999-05-10
K983408	Dried Gram-Negative and Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1999-05-10
K991436	Sterngold Implamed Narrow Platform Dental Implants and Related Prosthetics and Instrumentation	Sterngold	DZE	Class II	1999-05-07
K990756	Flow Line	Kulzer GmbH	EBF	Class II	1999-05-07
K990678	Pneumatic Demand Oxygen Conserver (Pdoc)	Salter Labs	NFB	Class II	1999-05-07
K990507	Acid Concentrate and Powder, Acetate Concentrate Liquid and Powder, and Bicarbonate Concentrate Liquid and Powder	Althin Biopharm, Inc.	KPO	Class II	1999-05-07
K983039	Emcee Infusion Introducer Sheath, Emcee Infusion Introducer Set Dilator, Emcee Infusion Introducer Sheath Set, Emcee Inf	Schneider/Namic	DYB	Class II	1999-05-07