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 1761 of 3531

510(k) clearances, page 1761 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984363	Xps Tissue Aspiration System, Xps Straightshot or Model 2000 Microdebrider System	Xomed, Inc.	BTA	Class II	1999-02-26
K983541	Hsv 1+2 Igg Elisa Test	Gull Laboratories, Inc.	LGC	Class II	1999-02-26
K983534	7F Hydrolyser Thrombectomy Catheter	Cordis US Corp.	QEZ	Class II	1999-02-26
K983204	Harwill Medical U-Klip Umbilical Clamp	Harwill Medical (Pty), Ltd.	HFW	Class II	1999-02-26
K982663	Stimulan- Calcium Sulfate Bone Void Filler	Encore Orthopedics, Inc.	MQV	Class II	1999-02-26
K982380	Sure	Pleasure Latex Products Sdn. Bhd.	HIS	Class II	1999-02-26
K981865	Mtm Bioscanner K Test Strips	Polymer Technology Systems	JMK	Class I	1999-02-26
K981125	Medcomp Tesio Catheter, Models Mbr-6, Mbl-6, Mbs-6	Medical Components, Inc.	MSD	Class II	1999-02-26
K973865	Birtcher UV Lamp	Medfaxx, Inc.	MXG	Class II	1999-02-26
K990252	Solo Plus Ortho	Sybron Dental Specialties, Inc.	DYH	Class II	1999-02-25
K990225	Endo Analyzer, Model 8005, Modified	Sybron Dental Specialties, Inc.	EAT	Class II	1999-02-25
K990168	Microlife It2ca1	Microlife Systems AG	FLL	Class II	1999-02-25
K990155	Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement, Model 70010	Kay See Dental Mfg. Co.	EMA	Class II	1999-02-25
K990143	Gluma One Bond	Kulzer GmbH	KLE	Class II	1999-02-25
K984545	Release 2 of Philips Integris Series (V5000, Bv5000, H5000, Bh5000, Hm2000) Systems	Philips North America LLC	IZI	Class II	1999-02-25
K984365	Gc Unifast Trad	GC America Inc.	EBI	Class II	1999-02-25
K984247	Elipar Trilight	Espe Dental AG	EBZ	Class II	1999-02-25
K983985	Hybrisonic Sheath	Sonotech, Inc.	ITX	Class II	1999-02-25
K983110	Flexart,flexart/hyper, Visart, Visart/hyper	Toshiba America Mri, Inc.	LNH	Class II	1999-02-25
K990429	Modification of Venturi Ventilator	Cardiopulmonary Corp.	CBK	Class II	1999-02-24
K990400	Linear Array Transducer,model Hp 21376, M2410a Ultrasound Imaging System	Hewlett-Packard Co.	ITX	Class II	1999-02-24
K990288	Free Flow Safety Device, Model Mg 245052	Teva Medical, Ltd.	FPA	Class II	1999-02-24
K990268	Laglove Brand Polymer Coated Latex Examination Glove (Powder Free)	La Glove (M) Sdn. Bhd.	LYY	Class I	1999-02-24
K990223	Modification of Clearplan Easy Fertility Monitor	Unipath, Ltd.	NGE	Class I	1999-02-24
K990219	Modification of Millennium	Biolase MG LLC	MXF	Class II	1999-02-24
K990008	Erco-Ribbon -C	Ercons, Inc.	LKY	Class II	1999-02-24
K990006	Erco-Vac -C	Ercons, Inc.	LKY	Class II	1999-02-24
K990003	J-Series Omega Total Hip System	Osteoimplant Technology, Inc.	LPH	Class II	1999-02-24
K984585	Osteonics +10 Unipolar Adaptor Sleeve	Osteonics Corp.	KWL	Class II	1999-02-24
K984467	Fusicryl	Micro Dental Laboratories	EBI	Class II	1999-02-24
K984432	Dall-Miles Cable Grip (a-Grip)	Howmedica Osteonics Corp	JDQ	Class II	1999-02-24
K984417	Bipolar Grasping Forceps Biq+	OLYMPUS Corporation of the Americas	GEI	Class II	1999-02-24
K984310	Moss Tubes, Inc, All Silicone Gastrostomy Tube	Moss Tubes, Inc.	KNT	Class II	1999-02-24
K984254	Infant Flow Ncpap Masks	Sensor Medics Corp.	BZD	Class II	1999-02-24
K984251	Xia Spine System	Howmedica Corp.	KWQ	Class II	1999-02-24
K983834	Echelon Hip Stem	Smith & Nephew, Inc.	LPH	Class II	1999-02-24
K983648	Sigma Plus/ II Multiplace Hyperbaric System	Perry Baromedical Services	CBF	Class II	1999-02-24
K983634	Prepare Home Infusion Pump	Medical Infusion Technologies, Inc.	MEB	Class II	1999-02-24
K983144	Flexposure Retractor	Endius, Inc.	HRX	Class II	1999-02-24
K980751	Sabratek 4040 Infusion Pump	Sabratek Corp.	FRN	Class II	1999-02-24
K980386	Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,a0/b and A0/0), Multiflow 100 Kits B22 (B22,b22/b, & B22/0)	Gambro Healthcare	KDI	Class II	1999-02-24
K990337	Ontrak Testcup-5 M2k	Roche Diagnostics GmbH	DKZ	Class II	1999-02-23
K984619	Binding Site Bindazyme Anti-Gbm Eia Diagnostic Test Kit	The Binding Site	MVJ	Class II	1999-02-23
K984244	Orl-E-92 Surgical Drill System	Bien Air USA	EFB	Class I	1999-02-23
K984220	Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh	Ethicon, Inc	FTL	Class II	1999-02-23
K983471	Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter	Radi Medical Systems AB	DXC	Class II	1999-02-23
K982967	Reliefband Mst Device, Models Rb-2, Rb-6, Rb-R	Woodside Biomedical, Inc.	GZJ	Class II	1999-02-23
K982363	Oasis Thrombectomy Catheter System	Boston Scientific Corporation	MCW	Class II	1999-02-23
K990380	(1) Digital Blood Pressure Monitor, Model Md-250; (2) Fully Automatic Blood Pressure Monitor, Model Md-700	Meditec Co., Ltd.	DXN	Class II	1999-02-22
K990373	Fact Plus One Step Pregnancy Test	Abbott Medical	LCX	Class II	1999-02-22