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 1433 of 3531

510(k) clearances, page 1433 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K030668	Model 3100 Wristox Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	2003-10-17
K022809	Ez Splint & Ez Splint Pm	Power Products, Inc.-Splintek	MQC	Unclassified	2003-10-17
K033244	Digital Fluoroscopic Imaging System, Model Innova 4100 with Tilt Table Option	GE Healthcare	OWB	Class II	2003-10-16
K033225	Evis Exera Bronchofibervideoscope Olympus Bf Type Xp160f, Its Accessories and Ancillary Equipment	Olympus Optical Co., Ltd.	EOQ	Class II	2003-10-16
K033196	Sonoline Antares with Clarify Ve	Siemens Medical Solutions USA, Inc.	IYN	Class II	2003-10-16
K033099	Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109	Applied Diabetes Research, Incorporated	FPA	Class II	2003-10-16
K033009	Roche Diagnostics Cobas Integra Albumin Gen. 2	Roche Diagnostics GmbH	CIX	Class II	2003-10-16
K032546	Hologic Dr Imagepro	Hologic, Inc.	LLZ	Class II	2003-10-16
K032533	Intelepacs	Intelerad Medical Systems Incorporated	LLZ	Class II	2003-10-16
K032480	Autoset Spirit System	ResMed Corp	BZD	Class II	2003-10-16
K032456	Prowess	Prowess, Inc.	MUJ	Class II	2003-10-16
K032428	Magnetom Avanto Mr System	Siemens Medical Solutions USA, Inc.	LNH	Class II	2003-10-16
K032340	Vistakon (Galyfilcon a) Soft Contact Lens	Johnson & Johnson Vision Care, Inc.	LPL	Class II	2003-10-16
K032257	Model Ir 1200 Insulin Pump	Animas Corp.	LZG	Class II	2003-10-16
K032226	Ltv-1000 Ventilator	Pulmonetic Systems, Inc.	CBK	Class II	2003-10-16
K031966	Enk Fiberoptic Atomizer Set	Cook Inc.	EOQ	Class II	2003-10-16
K031501	Easygluco, Model Igm0002	American Healthcare Corp.	NBW	Class II	2003-10-16
K031335	Powder Free Latex Exam Gloves	Tan Sin Lian Industries Sdn. Bhd.	LYY	Class I	2003-10-16
K031278	Stryker Flexible Ureteroscope	Stryker Corp.	FGB	Class II	2003-10-16
K031189	Uuhc Reprocessed Compression Sleeve Devices	University of Utah Hospitals and Clinics	JOW	Class II	2003-10-16
K031012	Attest Rapid Readout Biological Indicator for Eo, Model 1294; Attest Rapid Readout Biological Indicator for Eo Test Pack	3M Company	FRC	Class II	2003-10-16
K030857	Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic Accessories	Mahe Intl., Inc.	EOB	Class II	2003-10-16
K033179	Medela Clario Home Care Pump	Medela AG	BTA	Class II	2003-10-15
K032997	Modification to: Horizon 9000Ws	Mennen Medical, Inc.	DXG	Class II	2003-10-15
K032926	EKG Speaks	Medtronic, Inc.	KRE	Class II	2003-10-15
K032919	C.t.m. Mobility Scooter, Model Hs-250	C.T.M. Homecare Product, Inc.	INI	Class II	2003-10-15
K032792	Pre-Powdered, Non-Sterile, Vinyl Exam Gloves, Yellow	Shanghai Jiawang Industrial Co., Ltd.	LYZ	Class I	2003-10-15
K032683	Genesis II Porous Plus Ha Knee System	Smith & Nephew, Inc.	MBH	Class II	2003-10-15
K032408	Damon Ft	Sybron Dental Specialties, Inc.	DYW	Class II	2003-10-15
K032223	Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch	Cook Vandergrift, Inc.	GEI	Class II	2003-10-15
K032178	Rhythm Touch Q 2-Way	Shockim Enterprises, Ltd.	IPF	Class II	2003-10-15
K032167	Bio-Intrafix Tibial Screw and Sheath	Mitek Worldwide	HWC	Class II	2003-10-15
K031732	Ebi Acumen Surgical Navigation System	Ebi, LLC	HAW	Class II	2003-10-15
K031474	Sc Total Hip System	Orthopedic Alliance, LLC	JDI	Class II	2003-10-15
K031408	Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)	Deroyal	FYA	Class II	2003-10-15
K031301	Esteem Sterile Polyisoprene Surgical Gloves with Coating	Cardinalhealth	KGO	Class I	2003-10-15
K031074	Digital Ambulatory ECG (Holter) Recorder	Datrix LLC	MWJ	Class II	2003-10-15
K030985	Breas Pv 10I CPAP System, Model Pv 10I	Vital Signs, Inc.	BZD	Class II	2003-10-15
K030468	Acura Elite Gravity Compensating Reservoir	Phoenix Biomedical Corp.	JXG	Class II	2003-10-15
K033214	Ekos Peripheral Infusion System	Ekos Corp.	QEY	Class II	2003-10-14
K033185	Cobas Integra Alp Ifcc Gen.2	Roche Diagnostics GmbH	CJE	Class II	2003-10-14
K033165	Preciset Dat Amphetamine Calibrators; Cfas Dat Qualitative Amphetamine Calibrators	Roche Diagnostics GmbH	DLJ	Class II	2003-10-14
K032904	Acucam Concept IV Fwt, Model 110-0185G1	Dentsply Intl.	EIA	Class I	2003-10-14
K032868	Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139	Corgenix, Inc.	MID	Class II	2003-10-14
K032661	Acon Quick-Check II Home Pregnancy Test Device (Cassette)	Acon Laboratories, Inc.	LCX	Class II	2003-10-14
K032186	Autoalign	Cortechs Labs, Inc.	LLZ	Class II	2003-10-14
K031769	E-Strip	Eemso, Inc.	EGJ	Class II	2003-10-14
K033168	Ge 0.2T Signa Profile/i Mr System	General Electric Co.	LNH	Class II	2003-10-10
K033162	Linical Chemistry Calibration Verifiers Levels a-E for Olympus Au Systems	Cliniqa Corporation	JJY	Class I	2003-10-10
K033152	Hac-12 and Hac-30 Head Array Coil	Mri Devices Corp.	MOS	Class II	2003-10-10