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 1445 of 3531

510(k) clearances, page 1445 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032217	14G Cormark Biopsy Site Identifier	Artemis Medical, Inc.	FZP	Class II	2003-08-21
K032209	Nomos Corvus 5.0M	Nomos Corp.	MUJ	Class II	2003-08-21
K032090	Neurovascular Array Coil, Model Nva-127-8	Mri Devices Corp.	MOS	Class II	2003-08-21
K032057	Toxcup Drug Screen Cup Amp/coc/met/opi/pcp/thc	Branan Medical Corp.	DIO	Class II	2003-08-21
K031994	Linvatec 300W Xenon Light Source	Linvatec Corporation	GCT	Class II	2003-08-21
K031954	Cooltouch Incorporated Modelct3 Nd:yag Surgical Laser Systems	New Star Lasers, Inc.	GEX	Class II	2003-08-21
K031907	Npac Digital Thermometer, Models Et 300, 301, 350, 351; Et 400, 401, 450, 451; Et 500, 501, 550, 551	Norm Pacific Automation Corp.	FLL	Class II	2003-08-21
K031885	Navigus Passive Head Restraint System, Model Hr-Xxx	Image-Guided Neurologics, Inc.	HBL	Class II	2003-08-21
K031771	Shimadzu Collimator R-30H	Shimadzu Corp.	IZX	Class II	2003-08-21
K031749	Bodyguard Infusion System	Caesarea Medical Electronics, Ltd.	FRN	Class II	2003-08-21
K031735	Centurion Ses Epikeratome	Alcon Laboratories	HNO	Class I	2003-08-21
K031677	Synthes (USA) Calvicle Hook Plate	Synthes (USA) Products LLC	HRS	Class II	2003-08-21
K031204	Dentaport Zx	J. Morita USA, Inc.	EKX	Class I	2003-08-21
K030574	Gluseal 5Ml Dispenser, 1 Ml Dispenser, .2 Ml Dispenser	Glustitch, Inc.	KMF	Class I	2003-08-21
K030367	Columbus (Ps)	Aesculap Inc	JWH	Class II	2003-08-21
K032283	Designs for Vision Fiberoptic Light	Designs for Vision, Inc.	GDB	Class II	2003-08-20
K032225	Ep-Workmate with Rpm System	Abbott Medical	DQK	Class II	2003-08-20
K032207	Cobra Cooled Surgical Probe, Model M004159670	Boston Scientific Corporation	GEI	Class II	2003-08-20
K032204	Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit	Vascular Solutions LLC	GEX	Class II	2003-08-20
K032198	Aesculap Yasargil Aneurysm Clip Phynox Booster Clip	Aesculap Inc	HCH	Class II	2003-08-20
K032191	Omnilight Fluorescent Pulsed Light System	Luxsano AB	GEX	Class II	2003-08-20
K032132	Tissuelink Floating Ball Model 23-201-1	Medtronic Navigation, Inc	GEI	Class II	2003-08-20
K031990	Elecsys Precicontrol Troponin T	Roche Diagnostics GmbH	JJX	Class I	2003-08-20
K031852	Sapphire Detachable Fiber Coils	Medtronic, Inc.	HCG	Class II	2003-08-20
K031698	Elecys Shbg Calcheck	Roche Diagnostics GmbH	JJX	Class I	2003-08-20
K031551	Northstar Lidocaine Iontophoretic Controller (Northstar Controller-D)	Vyteris, Inc.	KTB	Class II	2003-08-20
K031420	S & C -Bracket Adhesives	S & C Polymer GmbH	DYH	Class II	2003-08-20
K030957	Perfect Capsule	Milvella Pty., Ltd.	HQC	Class II	2003-08-20
K030490	Ism1+, Ims2+, and Utm+	Medicult A/S	MQL	Class II	2003-08-20
K030357	Quantix/or Device	Cardiosonix, Ltd.	DPW	Class II	2003-08-20
K030281	Cryotron 2 Cryotherapy Device	Cryonic Medical North America	MLY	Unclassified	2003-08-20
K030192	Duet System	Bioview	JOY	Class II	2003-08-20
K023902	Shape-Lockable Endoscopic Overtube	Usgi Medical	FED	Class II	2003-08-20
K023884	Modification Oria Spinal System	Ortho Tec, LLC	KWP	Class II	2003-08-20
K032375	Vaxcel Port, Models 45-336 and 45-338	Boston Scientific Corporation	LJT	Class II	2003-08-19
K032335	Mas Cardioimmune Probnp, Mas Cardioimmune Tl	Medical Analysis Systems, Inc.	JJY	Class I	2003-08-19
K032259	Pasco Mic and Mic/id Panels	Lee Laboratories, Inc.	JWY	Class II	2003-08-19
K032077	Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)	Seal Polymer Industries Bhd.	LZA	Class I	2003-08-19
K032011	Glovetex Powder Free White Nitrile Examination Gloves, Non-Sterile	Pt. Wrp Buana Multicorpora	LZA	Class I	2003-08-19
K032010	Glovetex Powder Free Nitrile Examination Gloves, Blue, Non-Sterile	Pt. Wrp Buana Multicorpora	LZA	Class I	2003-08-19
K031917	Medtronic Minimed Paradigm Polyfin Qr, Model Mmt 312L and 312S	Medtronic, Inc.	FPA	Class II	2003-08-19
K031584	Sirotorque L	Sirona Dental Systems GmbH	EBW	Class I	2003-08-19
K031566	Syndeo Pca Syringe Pump, Model 2L3113	Baxter Healthcare Corporation	MEA	Class II	2003-08-19
K031489	Pitanga	Syneron Medical, Ltd.	GEX	Class II	2003-08-19
K031433	Siemens Infinity Modular Monitors, Models Sc 7000, Sc 9000Xl and Sc 8000 with Vf3 Modifications	Siemens Medical Solutions USA, Inc.	DSI	Class II	2003-08-19
K031427	Electro Neuromuscular Stimulator, Model Bmls03-1	BioMedical Life Systems Inc.	IPF	Class II	2003-08-19
K031047	Mirage Vista Mask	ResMed Corp	BZD	Class II	2003-08-19
K030407	Advisor, Model 9200	Bci, Inc.	CCK	Class II	2003-08-19
K030222	Nx System	American Telecare, Inc.	DRG	Class II	2003-08-19
K032287	Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2003-08-18