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 1846 of 3531

510(k) clearances, page 1846 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973486	Life Pak 12	Physio Control, Inc.	MKJ	Class III	1998-01-09
K973478	Arthrocare Sinus Electrosurgery System	ArthroCare Corporation	GEI	Class II	1998-01-09
K973152	Gallini ABS Device	Gallini U.S., LLC	KNW	Class II	1998-01-09
K972747	Bi-O.k. Eo Gas Biological Test-Pak (269305,269310,269320)	Propper Mfg Co Inc	FRC	Class II	1998-01-09
K972640	Tina-Quant Alpha Particle-1-Antitrypsin Assay	Boehringer Mannheim Corp.	DEM	Class II	1998-01-09
K972639	Tina-Quant Haptoglobin	Boehringer Mannheim Corp.	DAD	Class II	1998-01-09
K972638	Tina-Quant Prealbumin	Boehringer Mannheim Corp.	JZJ	Class I	1998-01-09
K971888	Glutatect	Alden Scientific, Inc.	JOJ	Class II	1998-01-09
K970888	Iotec Trocar and Flexible Cannula	Iotec Industries	GCJ	Class II	1998-01-09
K970838	Somnus Model 30Xx Disposable Tri-Needle Coagulating Electrode	Somnus Medical Technologies, Inc.	GEI	Class II	1998-01-09
K970837	Somnus Model 6000 Disposable Tissue Coagulating Electrode	Somnus Medical Technologies, Inc.	GEI	Class II	1998-01-09
K970678	The Harvard Library	Harvard Apparatus, Inc.	MRZ	Class II	1998-01-09
K963591	Snoring Control Device	Kenneth Hilsen	LRK	Class II	1998-01-09
K974827	Triage(r) Cardiac Panel Calibration Verification Controls, Triag (R) Myoglobin Calibration Verification Controls, Triage	Biosite Incorporated	JJY	Class I	1998-01-08
K974766	Manan Techna-Cut Aspiration Needle	Medical Device Technologies, Inc.	KNW	Class II	1998-01-08
K974741	Manan Accura Needle	Medical Device Technologies, Inc.	GAA	Class I	1998-01-08
K974446	Manan Automatic Cutting Needle	Argon Medical Devices, Inc	KNW	Class II	1998-01-08
K974431	Chemo-Spike II Reconstitution Device	Medi-Dose, Inc.	LHI	Class II	1998-01-08
K974366	Ksea Plastic Trocars	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1998-01-08
K974204	Vistacam Omni and Viastcam Omni (Ic)	Air Techniques, Inc.	EIA	Class I	1998-01-08
K974149	Ambulatory X-12 Telemetry Module	Mortara Instrument, Inc.	DRG	Class II	1998-01-08
K974004	Automated Disposable Keratome (Adk)	Lasersight Technologies, Inc.	HNO	Class I	1998-01-08
K973983	Phillips Easy Vision Family Workstation Option Endo 3D	Philips North America LLC	LLZ	Class II	1998-01-08
K973887	Masimo Set Ms-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corporation	DQA	Class II	1998-01-08
K973872	Atrion Medical Coated Lacrimal Intubation Set	Atrion Medical Products, Inc.	OKS	Unclassified	1998-01-08
K973868	Sscs (Segmental Spinal Correction System)	Osteotech Inc	KWP	Class II	1998-01-08
K972851	Zippy	Pillar Technology, Inc.	ITI	Class II	1998-01-08
K972574	Stela Model Uj45 Pacing Leads	Ela Medical, Inc.	DTB	Class III	1998-01-08
K972184	Rusch Brillant Silicone Foley Catheter	Rusch Intl.	EZL	Class II	1998-01-08
K971442	Hughes Bladder and Bowel Training System(ad-T-18, Med-18,Med-1,Med-T-1,Medd-18,Med-38,Med-T-10,Med-T-25,Med-T-5	Humed, Inc.	KPN	Class II	1998-01-08
K970577	Glyde Dam Lollyes	Glyde USA, Inc.	MSC	Class II	1998-01-08
K970512	Bactec Myco/f Lytic Culture Vials	Becton Dickinson Microbiology Systems	MDB	Class I	1998-01-08
K974637	Electrodes/probes/devices	Ximed/Prosure/Injectx	FAS	Class II	1998-01-07
K973869	Trace Reagent Line for the Cobas Mira	Trace America, Inc.	CKA	Class I	1998-01-07
K973860	Ovulon Monitor	Conception Technology, Inc.	NGE	Class I	1998-01-07
K974609	Rep Cholesterol Profile Control-II	Helena Laboratories, Corp.	JJX	Class I	1998-01-06
K974604	Randox Iron	Randox Laboratories, Limited	JMO	Class I	1998-01-06
K974568	Chase Anastomosis Visualization Device	Chase Medical, Inc.	FQH	Class II	1998-01-06
K974369	Apollo 9500	Ion Laser Technology	EBZ	Class II	1998-01-06
K974296	Model 720 Series Full/semi Electric Bed 1120 Full Electric Bed	Invacare GmbH	FNL	Class II	1998-01-06
K974189	Elecsys Psa (on Elecsys 1010)	Boehringer Mannheim Corp.	LTJ	Class II	1998-01-06
K974145	V3 Valve	B.Braun Medical, Inc.	FPA	Class II	1998-01-06
K974070	Physio/1000	Physio Designs, Inc.	FNM	Class II	1998-01-06
K974065	Powder Free Hyproallergenic Examination Glove (with Low Protein Claim)	Tillotson Healthcare Corp.	LYY	Class I	1998-01-06
K973849	Bioabsorbable Bankart Tack	Hogan & Hartson	MAI	Class II	1998-01-06
K973837	Cls Stem, Wagner Revision Stem, Alloclassic Zweymuller Stem, Sl	Sulzer Orthopedics, Inc.	LZO	Class II	1998-01-06
K973835	Philips Easyvision Workstation	Philips North America LLC	LLZ	Class II	1998-01-06
K973831	Pre-Powdered Patient Examination Glove	Safe Glove, Ltd.	LYY	Class I	1998-01-06
K973020	Patient Examination Powder-Free Gloves	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	1998-01-06
K972921	Sanko Intraoral Dental X-Ray	Sanko X-Ray Manufacturing Co., Ltd.	EHD	Class II	1998-01-06