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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3200 of 3528

510(k) clearances, page 3200 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822264	Nagashima Sn Operator's Chair	Kelleher Corp.	GBB	Class I	1982-10-13
K822158	Open Heart Tray (Custom Designed)	Megaplast, Inc.	KDD	Class I	1982-10-13
K822130	Francis Nasal Tube	Tekna Med Corp.	FZE	Class II	1982-10-13
K821655	Duoderm Hydroactive Granules	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1982-10-13
K822847	Insta-Hold	Taub Industries	KKX	Class II	1982-10-08
K822814	EMG 100T	Thought Technology Ltd.	HCC	Class II	1982-10-08
K822808	Tdx Kenamycin	Abbott Medical	KJI	Class II	1982-10-08
K822795	Gabriel Digitrend	Gabriel Ent.	HCS	Class II	1982-10-08
K822782	Acuscreen	Ortho Diagnostic Systems, Inc.	GGW	Class II	1982-10-08
K822777	Therapeutic Drug Control	Icl Scientific	DIF	Class I	1982-10-08
K822751	Del Mar Avionics Model 551 Neurocorder	Del Mar Avionics			1982-10-08
K822720	Model 340 Spectrophotometer	Abbott Diagnostics	JJQ	Class I	1982-10-08
K822701	Fluorostat Fluorometer	Miles Laboratories, Inc.	KHO	Class I	1982-10-08
K822684	Endab Thyroid Uptake	IMMUNOTECH s.r.o.	CEE	Class II	1982-10-08
K822592	Advance Tm T-3 Uptake Assay	Syva Co.	KHQ	Class II	1982-10-08
K822571	Syringe Pump	Hirata Sangyo Co. USA, Inc.	FRN	Class II	1982-10-08
K822540	Count-10 Trol	Texas Immunology, Inc.	JJW	Class I	1982-10-08
K822441	Unimeter 330K	Boehringer Mannheim Corp.	CEM	Class II	1982-10-08
K822346	Histimune Enzyme-Ana Test	Icl Scientific	LJM	Class II	1982-10-08
K821884	Gastroccult Tm	Smithkline Diagnostics, Inc.	KHE	Class II	1982-10-08
K828313	Digital Radiography Examination Table	Engineering Dynamics Corp.			1982-10-07
K827744	Dynex Ultrasound Diagnostic Scanner	Elscint, Inc.			1982-10-07
K827704	Mm-22 Microtron	Instrument AB Scanditronix			1982-10-07
K822783	Flex Ice Freeze Pack	Igloo Corp.	IME	Class I	1982-10-06
K822780	Cervical Brace	Jerome Medical	JEC	Class II	1982-10-06
K822771	101 Neer Type Shoulder	Intermedics Orthopedics	HSD	Class II	1982-10-06
K822769	Thoratec Gas Sampling Connector	Thoratec Laboratories Corp.	CAI	Class I	1982-10-06
K822767	Universal Dynasplint	Dynasplint Systems, Inc.	IQI	Class I	1982-10-06
K822749	Pilling Diamond Knife	Narco Scientific	GDX	Class I	1982-10-06
K822748	Pilling Coin-Style Blade Gauge	Narco Scientific			1982-10-06
K822624	O.t.e. Biomedica B.a.s.i.s. Model 2381	Del Mar Avionics	IKN	Class II	1982-10-06
K822599	Keates I/a System Frigitronics 4000	Frigitronics of Connecticut, Inc.	HKP	Class II	1982-10-06
K822569	Tympanoplasty & Skin Dissectors	Kelleher Corp.	GDI	Class I	1982-10-06
K822562	Odonto-Scope	Treace Medical, Inc.	FSO	Class I	1982-10-06
K822386	Cotral I W/4.5 L/hr. Ultrafiltrat. Capa	Hospal Medical Corp.	FII	Class II	1982-10-06
K822220	Cooper Vision I/a System III Model 1500	CooperVision, Inc.	HQE	Class II	1982-10-06
K822201	Ear Cannulas	Kelleher Corp.	FGY	Class I	1982-10-06
K822077	Respiration Monitor Type Mr-10	New Dimensions in Medicine, Inc.	FLS	Class II	1982-10-06
K822056	Exer-Stim Controller	Th Charters, Inc.	IPF	Class II	1982-10-06
K828194	Laser Laparoscope	Laser Industries, Ltd.			1982-10-05
K827690	Spectra Mini, Ultraviolet Emitter for Dermatological Use	Daavlin Co.			1982-10-05
K827098	Sunroof Sunlamp	Sunfun Enterprises, Ltd.			1982-10-05
K827408	Ultra Imager	Honeywell, Inc.			1982-10-04
K822851	Disscap 080	Hospal Medical Corp.	FKQ	Class II	1982-10-04
K822779	Phonic Ear-Pe 845-Ppc	Phonic Ear, Inc.	ESD	Class I	1982-10-04
K822768	Electrocardiograph (74 Dps) #Ym-102	Sanyo Electric, Inc.	DPS	Class II	1982-10-04
K822754	Ear/ulcer Syringe	American Hospital Supply	KCP	Class I	1982-10-04
K822718	Series 7000 Bedside Patient Monitor	Marquette Electronics, Inc.	DSI	Class II	1982-10-04
K822700	Del Mar Model 5500 EEG Scanner	Del Mar Avionics	GWQ	Class II	1982-10-04
K822687	Reusable Fogarty Flexible Calibrator	American Edwards Laboratories	DWP	Class II	1982-10-04