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 2371 of 3531

510(k) clearances, page 2371 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915776	Knee Prosthesis Driver	Kim-Med, Inc.	HWR	Class I	1992-06-11
K915437	Critical Care Hospital Bed (Icu/ccu)	Hill-Rom Inc.	FNL	Class II	1992-06-11
K914753	Auto Suture(r) Articulating Endoscopic Clamp	United States Surgical, A Division of Tyco Healthc	GET	Class I	1992-06-11
K914752	Auto Suture(r) Articulating Endoscopic Scissors	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1992-06-11
K914588	Grieshaber Snare Instrument and Snare Cartridge	Grieshaber & Co.	GAW	Class II	1992-06-11
K913817	Monocrystant Ph-Reference Catheter, Modification	Synectics-Dantec	FFT	Class I	1992-06-11
K912904	Mentor Odyssey Phacoemulsification System	Mentor O & O, Inc.	HQC	Class II	1992-06-11
K912619	Bear 7 Ventilator	Bear Medical Systems, Inc.	CBK	Class II	1992-06-11
K912565	Micro-Coll Collagen Wound Spray	Micro-Coll	SEJ	Unclassified	1992-06-11
K911804	Infrasonics Ventilator Adult Star, Modification	Infrasonics Corp.	CBK	Class II	1992-06-11
K922422	Programmable Hearing System, Ite and Bte Types	Audioscience, Inc.	ESD	Class I	1992-06-10
K922401	4 Sure Tm Colostomy Pouch	Boston Pacific Medical, Inc.	EZQ	Class I	1992-06-10
K922301	Beltone Opera Clearvoice Ic, Itc (in the Canal)	Beltone Electronics Corp.	ESD	Class I	1992-06-10
K922013	Shimadzu Image Amplifier Ia-12Vma Series	Shimadzu Medical Systems	JAA	Class II	1992-06-10
K922011	Shimadzu Image Amplifier Ia-12Vda Series	Shimadzu Medical Systems	JAA	Class II	1992-06-10
K921275	Sony Laser Videodisc Recording System	Sony Medical Systems	LMB	Class I	1992-06-10
K920942	Olympus Au800 Clinical Chemistry Analyzer	Olympus Corp.	JJG	Class I	1992-06-10
K920831	Pca Total Hip System (Cementless Use)	Pfizer Hospital Products Group, Inc.	LPH	Class II	1992-06-10
K920223	Chem Chex Theophylline Control	Streck Laboratories, Inc.	LAW	Class I	1992-06-10
K920127	Electroencephalograph Recording System	Medelec Intl. Corp.	GWQ	Class II	1992-06-10
K915711	In the Ear Hearing Aid	Zenith-Omni H.C., Inc.	ESD	Class I	1992-06-10
K915658	Spectra ECG	Advanced Medical Products, Inc.	LOS		1992-06-10
K915342	Ud 2000 Video Option	Diagnostic Ultrasound Corp.	LLZ	Class II	1992-06-10
K915279	Neoprobe Portable Radioscope Detector	Neoprobe Corp.	IZD	Class I	1992-06-10
K915078	Morse Hemostatic Catheter Introducer Set	North American Instrument Corp.	DYB	Class II	1992-06-10
K904385	Janus Atac Eng Analysis System	Life-Tech Intl., Inc.	GWN	Class II	1992-06-10
K922348	Valtrac(r) Introducer Forcep	American Cyanamid Co.	HJE	Class II	1992-06-09
K922021	Unicalibrator Kit	American Bioproducts Co.	GIZ	Class II	1992-06-09
K921873	Quickanchor, Modification	Mitek Surgical Products, Inc.	JDR	Class II	1992-06-09
K921763	Tandem Icon QSR Ckmb Immunoenzymetric Assay	Hybritech, Inc.	JHY	Class II	1992-06-09
K921729	Optisol Corneal Storage Media Container/modified	Chiron Intraoptics	LYX	Unclassified	1992-06-09
K921728	Dexsol Corneal Storage Media Container, Modified	Chiron Intraoptics	LYX	Unclassified	1992-06-09
K921704	Immulite(r) Fsh	Cirrus Diagnostics, Inc.	CGJ	Class I	1992-06-09
K921701	Durafill Bond	Kulzer GmbH	KLE	Class II	1992-06-09
K921684	Ptt-La Test Kit	American Bioproducts Co.	GGW	Class II	1992-06-09
K921678	Ciba Corning Acs Folate Immunoassay	Ciba Corning Diagnostics Corp.	JIX	Class II	1992-06-09
K921665	Avk Control I & II	American Bioproducts Co.	GGC	Class II	1992-06-09
K921570	Ors-300	Mnlase, Inc.	JRM	Class I	1992-06-09
K921569	Ors-200	Mnlase, Inc.	JRM	Class I	1992-06-09
K921568	Ors-100	Mnlase, Inc.	JRM	Class I	1992-06-09
K921378	Imed Model Pc-4 Volumetric Infusion Pump/controlle	Imed Corp.	FRN	Class II	1992-06-09
K921363	Cascade 480	Helena Laboratories, Corp.	GKP	Class II	1992-06-09
K921344	Thrombo-Calibrator Kit	American Bioproducts Co.	GGN	Class II	1992-06-09
K921305	Glyco-Tek Affinity Column Kit	Helena Laboratories, Corp.	LCP	Class II	1992-06-09
K921286	Liquichek Lipids Control Levels 1 and 2	Bio-Rad	JJY	Class I	1992-06-09
K921232	Keane Uni Knee System with Porocoat	Depuy, Inc.	HSX	Class II	1992-06-09
K921229	Sterile/single Use Ophthalmic Conformers	Storz Instrument Co.	HQN	Class II	1992-06-09
K920985	Snowden-Pencer Irrigation Pump	Snowden-Pencer	HEI	Class II	1992-06-09
K920976	Bactidrop India Ink	Remel Inc	JTS	Class I	1992-06-09
K920975	Bactidrop Calcofluor White	Remel Inc	JTS	Class I	1992-06-09