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 2026-10-12, 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 3243 of 3528

510(k) clearances, page 3243 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820305	Ralco Collimators, Manual Radiographic	Tecnomed, Inc.	KPW	Class II	1982-03-04
K820295	Cin Agar Base	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1982-03-04
K820242	Digicuff	Novatec, Inc.	DXN	Class II	1982-03-04
K820178	Pi808 Mobile C-Arm Image Intensifier	Precise Optics	JAA	Class II	1982-03-04
K820100	Frosted Glass Slides	Stan-Pak Ent.	KEW	Class I	1982-03-04
K820072	Fe-Cult Plus	Gamma Biologicals, Inc.	KHE	Class II	1982-03-04
K813493	Enzygnost Tm Rubella Igm	Calbiochem-Behring Corp.	LFX	Class II	1982-03-04
K813489	Rocking/circulating Cyto-Therm II 3570	Cryosan, Inc.	KZL	Class II	1982-03-04
K813413	Lectin H	American Dade	KSI	Class II	1982-03-04
K813342	Gamma Chloroquine Diphosphate Solution	Gamma Biologicals, Inc.	KSK	Class II	1982-03-04
K813130	Sunglasses	Panlin Corp.	HQG	Class I	1982-03-04
K827104	Additional Terminal Support for Star Tm Basic System	General Electric Co.			1982-03-02
K820425	Otomet Model M-9 Hearing Instrument	Otomet Corp.	ESD	Class I	1982-03-02
K820409	Electronic Clinical Thermometer Temp Pr	Y	FLL	Class II	1982-03-02
K820408	Class of Casting Alloys Type IV or Alt	Howmedica Corp.	EJS	Class II	1982-03-02
K820407	Class of Precious Metal Casting Alloys	Howmedica Corp.	EJS	Class II	1982-03-02
K820406	Tmo Integrated Circuit System	Travenol Laboratories, S.A.	KRI	Class I	1982-03-02
K820405	Ground Aid Caphesive	Promedicon, Inc.	KNS	Class II	1982-03-02
K820398	Dahlberg Hearing Aid Model Al	Dahlberg Electronics, Inc.	ESD	Class I	1982-03-02
K820397	Amerifluor Theophylline Fluorescent Imm	American Diagnostic Corp.	LER	Class II	1982-03-02
K820362	Reuter Bobbin Ventila. Tube-Titanium	Richard'S Medical Equip., Inc.	ETD	Class II	1982-03-02
K820351	Cast Cutter/cast Saw/instrument	Black & Decker(Tm)	LGH	Class I	1982-03-02
K820338	Impact, Models 306/307	ZOLL Medical Corporation	BTA	Class II	1982-03-02
K820337	Impact, Model 303	ZOLL Medical Corporation	GCX	Class II	1982-03-02
K820328	Nickel-Based Dental Casting Alloy	Dentsply Intl.	EJH	Class II	1982-03-02
K820318	Special White	J. Aderer, Inc.	EJT	Class II	1982-03-02
K820304	Gambro Gf-80-M, Gf-80-H Hemodialyzer	Gambro, Inc.	FJI	Class II	1982-03-02
K820292	Extractor III	The Anspach Effort, Inc.			1982-03-02
K820258	Deknatel Disposable Goosen Vascular Pnch	Howmedica Corp.	DWS	Class I	1982-03-02
K820244	Add'l Terminal Support for Star Basic	General Electric Co.	IYX	Class I	1982-03-02
K820182	Sybron/kerr Command	Sybron Corp.	EBF	Class II	1982-03-02
K820171	Subclavian Insertion Kit	Clinipad Corp.	FRG	Class II	1982-03-02
K820157	Xomed Thermal Myringotomy System	Xomed, Inc.	HQP	Class II	1982-03-02
K820145	Alltek Brompton Encoder	Alltek Hospital Supplies, Ltd.	DXK	Class II	1982-03-02
K820143	Xenon Delivery System	Vital Signs, Inc.	IYT	Class II	1982-03-02
K820057	Luxor Porcelain	Jeneric Ind.	EIH	Class II	1982-03-02
K813548	Uvex Mini-Specs	Bacou USA, Inc. and Uvex Safety, Inc.	HOI	Class I	1982-03-02
K813532	Cutterbond Zinc Phosphate Cement	Cutter Laboratories, Inc.	EMA	Class II	1982-03-02
K813397	Ssd-240 Ultrasonic Scanner	U. S. A. Imaging Corp.	IYO	Class II	1982-03-02
K812802	Capd u.v. Germicidal Connection System	Travenol Laboratories, S.A.	KDJ	Class II	1982-03-02
K820404	PEEP Valve	Vital Signs, Inc.	BYE	Class II	1982-03-01
K820382	Frog Splint	Conco Medical Co.	ILH	Class I	1982-03-01
K820381	Finger Protector	Conco Medical Co.	ILH	Class I	1982-03-01
K820380	Curved Finger Splint	Conco Medical Co.	ILH	Class I	1982-03-01
K820366	Becsic Collar	Blackstone & Breglio Industries	IQK	Class I	1982-03-01
K820354	Atmos Mirror Warmer	JEDMED Instrument Company	KAI	Class I	1982-03-01
K820350	Rionet Hearing Aid Hb-71S	Rion Acoustic Instruments, Inc.	ESD	Class I	1982-03-01
K820349	Rionet Hearing Aid Hb-71H	Rion Acoustic Instruments, Inc.	ESD	Class I	1982-03-01
K820348	Rionet Hearing Aid Hb-69As	Rion Acoustic Instruments, Inc.	ESD	Class I	1982-03-01
K820320	Model 3030 Atomic Absorption Spectro-	Revvity Health Sciences, Inc.	JXR	Class I	1982-03-01