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 1367 of 3531

510(k) clearances, page 1367 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041899	Vectorvision Uni-Knee	Brainlab, Inc.	HAW	Class II	2004-10-06
K041854	Mpm System	Aerotel Medical Systems, Ltd.	DXN	Class II	2004-10-06
K041598	Laserex, Model Lp4532	Ellex Medical Pty Ltd	HQF	Class II	2004-10-06
K042651	Free T3 Calibrators on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2004-10-05
K042535	Adventure A10	Ulrich Alber GmbH	ITI	Class II	2004-10-05
K042417	Zoll M Series Etc02 Loflo Option	ZOLL Medical Corporation	MKJ	Class III	2004-10-05
K042397	Scanx 14	Air Techniques, Inc.	MQB	Class II	2004-10-05
K042232	Np-2600 Series Hardcopy Printers	Codonics, Inc.	LMC	Class II	2004-10-05
K042137	Promedical Surgical Mayo Stand Covers, Band Bags, Table Covers and Equipment Covers	Promedical Products Co., Ltd.	KKX	Class II	2004-10-05
K041858	Acumed Anatomic Radial Head System	Acumed LLC	KWI	Class II	2004-10-05
K041698	Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor	TORNIER Inc.	MAI	Class II	2004-10-05
K042540	Philips Iu22 Ultrasound System	Philips North America LLC	IYO	Class II	2004-10-04
K042372	Hds Intra-Oral Imaging System	Vatech Value Added Technology Co., Ltd.	MUH	Class II	2004-10-04
K042368	Practix Convenio	Philips North America LLC	IZL	Class II	2004-10-04
K042258	Bp-Spect V1.o	Syntermed, Inc.	KPS	Class II	2004-10-04
K042243	Microalbumin Multi-Calibrator Set	Sekisui Diagnostics P.E.I. Inc.	JIX	Class II	2004-10-04
K042236	G-Scan	Esaote S.p.A.	LNH	Class II	2004-10-04
K041919	Perfudrop Air M-P with Needle 20 G, Model 48451606	Clinico	FPA	Class II	2004-10-04
K041122	Precision Liquid Oxygen System	Precision Medical, Inc.	BYJ	Class II	2004-10-04
K040601	Exactech Acumatch a-Series & Mcs Constrained Acetabular Liners	Exactech, Inc.	KWZ	Class II	2004-10-04
K040334	Navigus Passive Probe, Model Np-1000	Image-Guided Neurologics, Inc.	HAW	Class II	2004-10-04
K040189	Endometrial Sampling Syringe	Rocket Medical	HHK	Class II	2004-10-04
K033589	Baxter Duplotip Surgical Sealant Applicator	Micromedics, Inc.	FMF	Class II	2004-10-04
K031238	Varices Needle	Scandimed. A.S.	FBK	Class II	2004-10-04
K042525	Centricity Radiology Ra600/centricity Cardiology Ca1000/centricity Digital Hardcopy Workstation	GE Medical Systems Information Technologies, Inc.	LLZ	Class II	2004-10-01
K042518	Zilver 518 Biliary Stent	Cook Inc.	FGE	Class II	2004-10-01
K042503	Kurz Clip Piston Mvp, Model 1006 711-13/0.4 Mm + 1006 761-63/0.6Mm	Heinz Kurz GmbH Medizintechnik	ETA	Class II	2004-10-01
K042467	Lso Pet/ct Hirez 64	Siemens Medical Solutions USA, Inc.	KPS	Class II	2004-10-01
K042402	Modification to Vertex Reconstruction System	Medtronic Sofamor Danek	KWP	Class II	2004-10-01
K042070	Heparin Dose Response Cartridge, Model 304-20	Medtronic, Inc.	JOX	Class II	2004-10-01
K042037	M2a Magnum System	Zimmer GmbH	KWA	Class III	2004-10-01
K041962	Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589, 20603, 20604, 20605	Abbott Medical	FGE	Class II	2004-10-01
K041808	Endius Title 2 Polyaxial Spinal System	Endius, Inc.	KWP	Class II	2004-10-01
K041714	E-Pain Care	Breg, Inc.	FRN	Class II	2004-10-01
K041389	Synthes Contoured Synmesh Spacer	Synthes GmbH	MQP	Class II	2004-10-01
K041211	Powered Wheelchair, Model C-1000	Otto Bock Healthcare LP	ITI	Class II	2004-10-01
K041210	Powered Wheelchair, Model B-600	Otto Bock Healthcare LP	ITI	Class II	2004-10-01
K041208	Powered Wheelchair, Model B-500	Otto Bock Healthcare LP	ITI	Class II	2004-10-01
K041062	Intrauterine Venogram Needle Set	Cook Incorporated	LKF	Class II	2004-10-01
K040889	Exactech Optetrak Unicondylar Knee	Exactech, Inc.	HRY	Class II	2004-10-01
K040849	Mentamove	Cole & Associates	IPF	Class II	2004-10-01
K040311	Shian Jia Meei Digatal Pwn TENS, Model Yw-6000/Uc-332/Uc-330/St-331	Shian Jia Meei Enterprise Co., Ltd.	GZJ	Class II	2004-10-01
K042575	Amplife Digital Clinical Thermometer	Amplife Corporation	FLL	Class II	2004-09-30
K042490	Elecsys Folate II Calset II	Roche Diagnostics GmbH	JIT	Class II	2004-09-30
K042488	Perifix Catheter and Contiplex Catheter	B.Braun Medical, Inc.	BSO	Class II	2004-09-30
K042464	V-Core Full Core Breast Biopsy Instrument	Medical Device Technologies, Inc.	KNW	Class II	2004-09-30
K042425	Autodelfia Neonatal 17A-Oh-Progesterone Kit	Wallac Oy	JLX	Class I	2004-09-30
K042424	Delfia Neonatal 17A-Oh-Progesterone Kit	Wallac Oy	JLX	Class I	2004-09-30
K042364	Panbus Digital EEG & Sleep Acquisition Devices	Lamont Medical, Inc.	OLV	Class II	2004-09-30
K042267	Inovel Health Care N95 Particulate Respirator and Surgical Mask, Models 3001N95-S, 3002N95-M, 3003N95-L, and 3004N95-Lp	Moldex/Metric, Inc.	MSH	Class II	2004-09-30