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 1995 of 3531

510(k) clearances, page 1995 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961025	Expanded Body Suture	Medicinelodge, Inc.	GAT	Class II	1996-04-15
K960906	Foundation Glenoid Component	Encore Orthopedics, Inc.	KWS	Class II	1996-04-15
K960732	Hydrospot EEG Electrode Model 1501, Hydrospot Leadwire Model 1500	Physiometrix, Inc.	GXY	Class II	1996-04-15
K960698	Non-Coring Needle	Med Institute, Inc.	FMI	Class II	1996-04-15
K960542	Noga	Biosense, Ltd.	DRF	Class II	1996-04-15
K960514	Tmp Mandibular Compression System (Modification)	Anspach Fixation Systems	JEY	Class II	1996-04-15
K960364	Cu-200 Light Cure Unit	Rolence Enterprise Co., Ltd.	EBZ	Class II	1996-04-15
K960361	Permamesh-D Hydroxylapatite Matrix	Ceramed Corp.	LYC	Class II	1996-04-15
K960351	Q-Lux Light Cure Unit	Rolence Enterprise Co., Ltd.	EBZ	Class II	1996-04-15
K960350	Theraport Vascular Access System; Model 1001, 1002, 1601, 1602	Biocontrol Technology, Inc.	LJT	Class II	1996-04-15
K960292	Gore-Tex Regenerative Material Titanium Reinforced Configurations	W. L. Gore & Associates, Inc.	NPK	Class II	1996-04-15
K960262	Coring Morcellator	Cook Incorporated	HET	Class II	1996-04-15
K960216	CPR Suction Catheter Kit	Custom Pack Reliability	JOL	Class II	1996-04-15
K960195	Thyrochek One-Step Rapid Tsh Assay	Franklin Diagnostics, Inc.	JLW	Class II	1996-04-15
K960169	Carbomedics Valve Tester	Carbomedics, Inc.	DTJ	Class I	1996-04-15
K960144	G.e. Sterile CT Biopsy Tray	GE Healthcare	DWS	Class I	1996-04-15
K955419	Powder Free Tactylon Surgeons Glove	Tactyl Technologies, Inc.	KGO	Class I	1996-04-15
K955176	Dento-Surge	Ellman Intl., Inc.	EKZ	Class II	1996-04-15
K955108	Cards Q.s. Strep a	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1996-04-15
K954967	Guthrie Powderfree Latex Examination Gloves	Guthrie Medicare Products (Melaka) Sdn Bhd	LYY	Class I	1996-04-15
K954842	D.o.r.c. Vfi/vfe System	Dutch Ophthalmic USA, Inc.	KYG	Class I	1996-04-15
K954735	Enteralite	Zevex Intl., Inc.	LZH	Class II	1996-04-15
K954471	Powers Anti-Bacterial Valve	Powers Dental & Medical Technology, Inc.	EIA	Class I	1996-04-15
K954272	Innova Rectal Stimulaton Electrode	Empi	KPI	Class II	1996-04-15
K953185	Platinum Series Ep Diagnostic Catheters	Medtronic Cardiorhythm	DRF	Class II	1996-04-15
K951994	Olympus EU-M30 Endoscopic Ultrasound Center	OLYMPUS Corporation of the Americas	IYO	Class II	1996-04-15
K951359	Rubella Igg Assay for the Technicon Immuno 1 System in-Vitro Diagnostic Device	Bayer Corp.	LFX	Class II	1996-04-15
K950972	Real-Time Reconstruction System Model Tsxf-001A	Toshiba America Medical Systems, In.C	JAK	Class II	1996-04-15
K945957	Ausonics Opus 2 Realtime Ultrasound Scanner	Kleinfeld, Kaplan and Becker	IYN	Class II	1996-04-15
K932994	Evoked Potential System-1.0	Neuromedical Systems, Inc.	GWF	Class II	1996-04-15
K960406	Braun Hemostasis Introducers	B.Braun Medical, Inc.	DYB	Class II	1996-04-12
K960248	General Procedure Kit	Physician Industries, Inc.	FMF	Class II	1996-04-12
K960213	CPR Total Hip Pack	Custom Pack Reliability	FRG	Class II	1996-04-12
K960211	CPR Total Knee Pack	Custom Pack Reliability	FRG	Class II	1996-04-12
K960210	CPR Ortho Hand Pack	Custom Pack Reliability	FRG	Class II	1996-04-12
K960206	CPR Dressing Change Tray	Custom Pack Reliability	FRG	Class II	1996-04-12
K955251	Oec 902, 901 Nasa II, Oec 902, 901 Nasa I Ccd C-Arm	Imaging Services, Inc.	OXO	Class II	1996-04-12
K954759	Flowmate Lte	Spirometrics Medical Equipment Co.	BZG	Class II	1996-04-12
K954567	Rti Medical	Radiology Telenetwork Intl.	LMD	Class I	1996-04-12
K954354	Magnetic Resonance Diagnostic Accessory	General Electric Co.	LNH	Class II	1996-04-12
K954353	Magnetic Resonance Diagnostic Accessory	General Electric Co.	LNH	Class II	1996-04-12
K953872	Second Ear Bone Conduction Hearing Aid	Wordcomp International Communication Group (Wicg)	LXB	Class II	1996-04-12
K943338	Biosensor Bidop Vascular Test System	Biosensor Corp.	JAF	Class II	1996-04-12
K960792	Disposable Neuroview Introducer Sheath	Neuro Navigational Corp.	GWG	Class II	1996-04-11
K955589	Ferticare Personal Therapeutic Vibrator	Multicept, ApS.	KXQ	Class II	1996-04-11
K955166	Penevac Si.	I.C. Medical, Inc.	GEI	Class II	1996-04-11
K954760	Lmi Arterial Embolectomy Catheter	Lucas Medical, Inc.	DXE	Class II	1996-04-11
K951343	Karl Storz Semi-Rigid Micro-Endoscopes & Accessories for Endosccopic Gynecological Surgical Procedures	Karl Storz Endoscopy-America, Inc.	HET	Class II	1996-04-11
K950294	Flexlens 55 Soft (Hydrophilic) Contact Lens	Flexlens, Inc.	LPL	Class II	1996-04-11
K961035	US-Holo Sunglasses	Mi Technologies, Inc.	HQY	Class I	1996-04-10