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 1816 of 3531

510(k) clearances, page 1816 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980952	Snore-Cure Anti-Snoring Appliance	Ortho-Tain, Inc.	LRK	Class II	1998-06-01
K980826	Equidose Solid State Diode Detectors	Cii Mastek, Inc.	IYE	Class II	1998-06-01
K980100	Storz Dp4210 Venturi Economy Anterior Pack and Dp5000 Asc Daypack	Storz Instrument Co.	MSR	Class II	1998-06-01
K974812	Cobe(r) Cml Duo(r) with Smart(tm) Surface Modified Membrance Oxygenator	LivaNova USA, Inc.	DTZ	Class II	1998-06-01
K974106	Icon Implant System	Bio Science Technologies, Inc.	DZE	Class II	1998-06-01
K973936	Focus Rtp System	Elekta Limited	IYE	Class II	1998-06-01
K971007	Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igm (Wb0400m)	Mrl Diagnostics	LSR	Class II	1998-06-01
K971006	Lyme Disease B. Burgdorferi Genogroup 1 Western Blot Igg (Wb0400g)	Mrl Diagnostics	LSR	Class II	1998-06-01
K964332	Eagle Century Steam Sterilizer	Amsco Intl., Inc.	FLE	Class II	1998-06-01
K981700	Vasoview Dissection/vessel Harvesting System	Origin Medsystems, Inc.	GCJ	Class II	1998-05-29
K981491	Urosurge Filastent Ureteral Stent	Urosurge, Inc.	FAD	Class II	1998-05-29
K981489	Urosurge Spirastent Plus Ureteral Stent	Urosurge, Inc.	FAD	Class II	1998-05-29
K981389	Disposable Re-New Forceps	Microline Pentax, Inc.	GEI	Class II	1998-05-29
K981388	Micro-Strip for Cocaine Metabolites	Microdiagnostics, Inc.	DIO	Class II	1998-05-29
K981296	Geen Medisox	Geen Healthcare, Inc.	DWL	Class II	1998-05-29
K981240	Creatinine (Crea)	Abbott Medical	CGX	Class II	1998-05-29
K981201	Osteolock Acetabular Cup	Howmedica Corp.	LZO	Class II	1998-05-29
K981113	Pediatric Prc	Acromed Corp.	MNH	Class II	1998-05-29
K980994	IV Administration Sets with Needle Access Devices	Venetec Intl., Inc.	FPA	Class II	1998-05-29
K980886	Babytherm 8000 Ldr	Draeger, Inc.	FMZ	Class II	1998-05-29
K980801	J-Fx Bipolar Head	Johnson & Johnson Professionals, Inc.	KWY	Class II	1998-05-29
K980780	Datascope Percor Stat-Dl 9.5 Fr. 25, 34 and 40Cc Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles	Datascope Corp.	DSP	Class II	1998-05-29
K980348	Etest Vancomycin	Ab Biodisk	JWY	Class II	1998-05-29
K980342	Etest Chloramphenical	Ab Biodisk	JWY	Class II	1998-05-29
K974771	Stryker Se5 Arthroscopy System with Hermes Voice Control	Stryker Corp.	GCJ	Class II	1998-05-29
K974678	B-D Auto-Injector	BD Becton Dickinson Vacutainer Systems Preanalytic	KZH	Class II	1998-05-29
DEN980001	Dynamic Orthotic Cranioplasty Band; Doc Band	Cranial Technologies, Inc.	MVA	Class II	1998-05-29
K981585	Abuscreen Online for Cannabinoids (1000 Test Kit)	Roche Diagnostic Systems, Inc.	LDJ	Class II	1998-05-28
K981584	Abuscreen Online for Cannabinoids (100 Test Kit)	Roche Diagnostic Systems, Inc.	LDJ	Class II	1998-05-28
K981512	Icon Fxhcg Urine/serum Test, Icon Fxhcg Urine Test, Models 40025,40050, 40005 & 41025	Skd, Inc. A Beckman Coulter Co.	JHI	Class II	1998-05-28
K981250	Licemeister Comb	National Pediculosis Assoc.	LJL	Class I	1998-05-28
K981134	Etest Tetracycline	Ab Biodisk	JWY	Class II	1998-05-28
K981012	Aia-Pack Myoglobin Assay	Tosoh Medics, Inc.	DDR	Class II	1998-05-28
K980992	IV Administration Sets with Needleless Access Devices	Venetec Intl., Inc.	FPA	Class II	1998-05-28
K980961	Cordis Webster Ref-Star Ex Surface Reference Device Model's D-1204-01, -02,-03, and -04.	Cordis Webster, Inc.	DRF	Class II	1998-05-28
K980763	Lysonix Lipoplasty Access Port	Lysonix, Inc.	QPB	Class II	1998-05-28
K980558	Painbuster Infusion System	Halyard Health	MEB	Class II	1998-05-28
K980431	Surgisis	Cook Biotech, Inc.	FTM	Class II	1998-05-28
K980338	Etest Ofloxacin	Ab Biodisk	JWY	Class II	1998-05-28
K974285	Periflux System 5000 Modular Laser Doppler System Main Unit Model Pf 5001, Including Pf 5010 Ldpm Unit	Perimed AB	DPW	Class II	1998-05-28
K972849	Isosafe Earloop Procedure Mask (Blue, Yellow)	Cypress Medical Products LLC	FXX	Class II	1998-05-28
K972502	Spacelabs Medical Integrated Multiparameter Module 90496	GE Healthcare	DSI	Class II	1998-05-28
K981626	Sonoline Elegra Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYO	Class II	1998-05-27
K981607	Active Renin Irma Model Number Dsl-25100	Diagnostic Systems Laboratories, Inc.	CIB	Class II	1998-05-27
K981468	Albg	Abbott Medical	CIX	Class II	1998-05-27
K981457	Albp	Abbott Mfg., Inc.	CJW	Class II	1998-05-27
K981373	Alkphase-B Assay Kit	Metra Biosystems, Inc.	CIN	Class II	1998-05-27
K981008	Simal Cervical Stabilization System	Top Surgical Products GmbH	KWQ	Class II	1998-05-27
K980989	3M Tegagen Hi Alginate Dressing & 3M Tegagen Hg Alginate Dressing	Innovative Technologies, Ltd.	KMF	Class I	1998-05-27
K980917	All Slicone Drainage, Penrose Drain, Cwv Drain, Thoracic Drain Tubes and Cwv Reservoir	Fortune Medical Instrument Corp.	GCA	Class II	1998-05-27