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 1789 of 3531

510(k) clearances, page 1789 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982896	Alexander Manufacturing Co. Rechargeable Battery Part Number Lp9	Alexander Mfg. Co.	LDD	Class II	1998-10-21
K982873	Zeta Multizone Scn Locking Nail	Howmedica Corp.	HSB	Class II	1998-10-21
K982862	Radworks Medical Imaging Software with Quality Control Module	Applicare Medical Imaging, B.V.	LLZ	Class II	1998-10-21
K982818	Hospal Tipstop	Gambro Healthcare	KMF	Class I	1998-10-21
K982787	Asteion CT Scanner, Tsx-021A	Toshiba America Medical Systems, In.C	JAK	Class II	1998-10-21
K982778	Bioderm Foam Wound Dressing	Bioderm, Inc.	KMF	Class I	1998-10-21
K982642	Echo-Screen	Fischer-Zoth Audiologic Systems, Inc.	EWO	Class II	1998-10-21
K982592	Docking-Extension Wire	Schneider (Europe) GmbH	DQX	Class II	1998-10-21
K982577	Neufinish Resurfacing Cream	Neutrogena Corp.	MGQ	Unclassified	1998-10-21
K982566	Automatic Self-Operated Screening Audiometer Device (Asam)	Bar - Advanced Control Systems, Ltd.	EWO	Class II	1998-10-21
K982013	Mgb Lapalux Telescope	Mgb Endoskopische Gerate GmbH	GCJ	Class II	1998-10-21
K981208	Tfr	Ramco Laboratories, Inc.	JNM	Class II	1998-10-21
K981004	Sle EMG Electrodes and Accessories	Specialized Laboratory Equipment, Ltd.	IKT	Class II	1998-10-21
K980601	Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader	Varian Assoc., Inc.	JAQ	Class II	1998-10-21
K980485	Isola Spinal System	Acromed Corp.	MNI	Class II	1998-10-21
K974891	Acutek's Hydrocolloid Wound Dressing, Tib 197013	Acutek Adhesive Specialties, Inc.	MGP	Unclassified	1998-10-21
K983037	Roeko Seal	Roeko Ulm, Roescheisen GmbH & Co.	KIF	Class II	1998-10-20
K982888	Vaxcel Impantable Vascular Access System	Boston Scientific Corporation	LJT	Class II	1998-10-20
K982699	Unigrafe	Unicare Biomedical, Inc.	LYC	Class II	1998-10-20
K981880	Dx-480, Add on Digital Imager	Wuestec Medical, Inc.	KPR	Class II	1998-10-20
K983406	Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for	Banta Healthcare Group, Ltd.	FLL	Class II	1998-10-19
K983381	Various Trade Tampons Sold Under Private Labels	Paragon Trade Brands, Inc.	HEB	Class II	1998-10-19
K983052	Peritron Perineometer Model 9300V or 9300A	Cardio Design Pty., Ltd.	HIR	Class II	1998-10-19
K982966	Disetronic Pen	Disetronic Medical Systems	FMF	Class II	1998-10-19
K982913	Zinfos Zinc Phosphate Cement	Scientific Pharmaceuticals, Inc.	EMA	Class II	1998-10-19
K982695	Gc Reline	GC America Inc.	EBI	Class II	1998-10-19
K982671	Securalloy	Specialites Septodont	EJJ	Class II	1998-10-19
K982548	Mlt 30 Laser	Medical Laser Technologies Ltd.	GEX	Class II	1998-10-19
K982545	Bmp Cable System	Zimmer GmbH	JDQ	Class II	1998-10-19
K982299	Spyglass 5 Fr Angiographic Catheter	Daig Corp.	DQO	Class II	1998-10-19
K981958	Leisegang Video Colposcope	Netoptix Corp.	HEX	Class II	1998-10-19
K983409	V-Cath Picc (Peripherally Inserted Central Catheter) See Appendix 1	Hdc Corp.	FOZ	Class II	1998-10-16
K983002	Mystique Ultrasonic Nebulizer	Airsep Corp.	CAF	Class II	1998-10-16
K982999	Greiner Minicollect Edta Blood Collection Tube	Greiner Meditech, Inc.	JKA	Class II	1998-10-16
K982917	B-System Silicone	Sybron Dental Specialties, Inc.	ELW	Class II	1998-10-16
K982866	Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay, Model # 62-701521	Nichols Institute Diagnostics	JZO	Class II	1998-10-16
K982786	Traccell 2000 Slide Mapping System	Accumed Intl., Inc.	JOY	Class II	1998-10-16
K982621	Quickscreen at Home Drug Test, Model 9149/9150	Phamatech Inc.	MVO	Unclassified	1998-10-16
K982531	Howmedica Leibinger Resorbable Fixation System	Howmedica Corp.	HRS	Class II	1998-10-16
K982530	Sullivan Mirage Full Face Mask	ResMed Corp	BZD	Class II	1998-10-16
K982508	Flexima	Boston Scientific Corporation	FGE	Class II	1998-10-16
K982499	Cosmo Plus with Nico, Model 8200	Novametrix Medical Systems, Inc.	BZC	Class II	1998-10-16
K982497	Arthrotek Interference Screw	Zimmer GmbH	HWC	Class II	1998-10-16
K982281	Seraquest Rubella Igm	Quest Intl., Inc.	LFX	Class II	1998-10-16
K981660	Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters	C.R. Bard Inc	DSP	Class II	1998-10-16
K980907	Axis Homocysteine Enzyme Immunoassay	Axis Biochemicals, ASA	LPS	Class II	1998-10-16
K980724	Tinaquant B 2-Microglobulin Assay	Boehringer Mannheim Corp.	JZG	Class II	1998-10-16
K980078	Penetrease	P.T. Panca Pusaka Deli	FMF	Class II	1998-10-16
K974774	Envy Guiding Catheter	Cook Inc.	DQO	Class II	1998-10-16
K965136	Urosurge Urotherm Fluid Warming System	Princeton Regulatory Assoc.	LHC	Class I	1998-10-16