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 2064 of 3531

510(k) clearances, page 2064 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950724	Model Int/dl40i Micro Computer Controller for Power Wheelchairs	Invacare GmbH	ITI	Class II	1995-08-07
K950493	Photoderm Vl.	Esc, Energy Systems Corp.	GEX	Class II	1995-08-07
K946348	Titanium Tsrh(r) Spinal System (Screws)	Sofamor Danek USA,Inc.	MNH	Class II	1995-08-07
K945940	Coatest(r) Apc(tm) Resistance	Axis-Shield Doc AS	GGW	Class II	1995-08-07
K945807	Homevue Wound Monitoring System	Homevue Health Systems, Inc.	LLZ	Class II	1995-08-07
K945773	Siemens Sonoline Versa	Siemens Medical Solutions USA, Inc.	IYN	Class II	1995-08-07
K945766	Hypoallergenic Powdered Ambidextrous Patient Examination Gloves	Ansell, Inc.	LYY	Class I	1995-08-07
K944961	Personal Alarm System (Pas)	Cytoprobe Corp.	LDQ		1995-08-07
K944874	Zeroid Hemorrhoidal Device	Medical Appliance Research Corp.	LKX	Unclassified	1995-08-07
K942380	Micro Ics Sonic Scaler	Micro Motors, Inc.	ELC	Class II	1995-08-07
K942200	Isolyser Orex Surgeon's Caps, Hoods, Bouffant Caps	Thantex Specialties, Inc.	LYU	Class I	1995-08-07
K941772	Cradle Fixation Device	Neoligaments, Ltd.	JDR	Class II	1995-08-07
K953321	Sas Shigella Dysenteriae Type 3 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K953320	Sas Shigella Dysenteriae Type 4 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K953319	Sas Shigella Dysenteriae Type 5 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K953318	Sas Shigella Dysenteriae Type 6 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K953317	Sas Shigella Dysenteriae Type 7 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K953316	Sas Shigella Dysenteriae Group a (1-7) Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-04
K952646	Il Test Ck-Mb	Instrumentation Laboratory Co.	CGS	Class II	1995-08-04
K952579	Toco Transducer	Scientific Device Manufacturer, LLC	HFM	Class II	1995-08-04
K952205	Acs Powerbase Guilding Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1995-08-04
K951694	Electronic Laparoflator	Karl Storz Endoscopy-America, Inc.	HIF	Class II	1995-08-04
K951597	Urinary Drainage Bag	Key Medical Services, Inc.	EYZ	Class I	1995-08-04
K951529	V. Mueller Obstetrical (Ob) Forceps	Baxter Healthcare Corporation	HDA	Class II	1995-08-04
K946229	Balance Manager	Neurocom International, Inc.	KHX	Class I	1995-08-04
K946075	Vitalograph Model 2120	Vitalograph, Inc.	BZG	Class II	1995-08-04
K945826	J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications	Medical Device Inspection Company	HCC	Class II	1995-08-04
K941624	Rubella Igg Elisa Test	Gull Laboratories, Inc.	LFX	Class II	1995-08-04
K940004	Ai-Photodiagnostic	Pharmarceutical Discovery Corp.	CIB	Class II	1995-08-04
K953444	Mci Optonix Economy Cassette	Mci Optonix	IXA	Class II	1995-08-02
K953338	Injection Needle	Boston Scientific Corporation	FBK	Class II	1995-08-02
K953329	Sas Shigella Boydii Group C2 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953328	Sas Shigella Boydii Type 7 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953327	Sas Shigella Boydii Type 6 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953326	Sas Shigella Boydii Type 5 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953325	Sas Shigella Boydii Type 4 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953324	Sas Shigella Boydii Type 3 Antiserun	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953323	Sas Shigella Boydii Type 2 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953322	Sas Shigella Boydii Type 1 Antiserum	SA Scientific, Ltd	GNB	Class II	1995-08-02
K953201	Imagyn Uroscope	Imagyn Medical, Inc.	FAJ	Class II	1995-08-02
K953020	Acs Gentamicin	Ciba Corning Diagnostics Corp.	LCD	Class II	1995-08-02
K952185	Cordis Brite Tip, Envoy Guiding Catheter	Cordis US Corp.	DQY	Class II	1995-08-02
K951751	Hichem Ast Reagent Kit	Hichem Diagnostics	CIT	Class II	1995-08-02
K951366	Riken Gas Indicator (3 Models, 1806H, 1802D, If-18)	Riken Keiki Co., Ltd.	CBS	Class II	1995-08-02
K951289	Axsym Cocaine Metabolite	Abbott Medical	DIO	Class II	1995-08-02
K950411	Relaxu-1	Kinsei Shiatsu, Inc.	ISA	Class I	1995-08-02
K950155	Rapid-Trak(tm) Introducer Sheath	Cardio Vascular Concepts, Inc.	DYB	Class II	1995-08-02
K950029	5Stratec Sl 300 Lia-Mat	Nichols Institute Diagnostics	JJQ	Class I	1995-08-02
K946080	Physio Control Lifepak 200 Auto Defibrillator	Portable Power Systems, Inc.	FCO	Class I	1995-08-02
K945965	Atraumatic Pencil Point Spinal Needle	Avid N.I.T., Inc.	BSP	Class II	1995-08-02