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 1265 of 3531

510(k) clearances, page 1265 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061111	Tinnitus Phase-Out	Tinnitus Control, Inc.	KLW	Class II	2006-05-16
K060881	Temporary Crown & Bridge Resin	Cosmedent, Inc.	EBG	Class II	2006-05-16
K060816	Mim 4.0 (Neuro	MIM Software Inc	LLZ	Class II	2006-05-16
K060783	Susceptibility Test Plate for Vancomycin Vrsa Limitation Removal	Trek Diagnostic Systems, Ltd.	JWY	Class II	2006-05-16
K060775	Powder-Free Latex Patient Examination Glove,with Extractable Protein Content Labelling Claim (50 Microgram per Gram of	Kossan Latex Industries (M) Sdn Bhd	LYY	Class I	2006-05-16
K060126	Absoanchor Microimplant	Dentos, Inc.	DZE	Class II	2006-05-16
K053230	Merits Health Products Oxygen Concentrators	Merits Health Products, Inc.	CAW	Class II	2006-05-16
K061216	Usgi Transport Endoscopic Guide	Usgi Medical	FED	Class II	2006-05-15
K061214	Aquariusaps Server	Terarecon, Inc.	LLZ	Class II	2006-05-15
K061185	Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-Cane05a and L-Cane05a Software	GE Healthcare	MHX	Class II	2006-05-15
K061140	Trilogy Radiotherapy Delivery System	Varian Medical Systems, Inc.	IYE	Class II	2006-05-15
K060989	Tissuemend Soft Tissue Repair Matrix	Integra LifeSciences Braintree Inc.	FTM	Class II	2006-05-15
K060934	Modification to Powerheart Ecd	ZOLL Medical Corporation	MKJ	Class III	2006-05-15
K060870	Avanza	Mds Nordion	JAI	Class II	2006-05-15
K060715	Modification to: Cardima Ablation System	Cardima, Inc.	OCL	Class II	2006-05-15
K060701	Biscem Translucent, Biscem Opaque	Bisco Inc	EMA	Class II	2006-05-15
K060516	Ellipse 12Pl, Model 9Esl7228	Danish Dermatologic Development A/S	GEX	Class II	2006-05-15
K060442	Pyrenees Cervical Plate System	K2M, Inc	KWQ	Class II	2006-05-15
K060321	Adscope 657Bk Electronic Stethoscope, Model 657Bk	American Diagnostic Corp.	DQD	Class II	2006-05-15
K060135	Mortara Surveyor Telemetry Central Station	Mortara Instrument, Inc.	MHX	Class II	2006-05-15
K052832	Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses	Sauflon Pharmaceuticals, Ltd.	MVN	Class II	2006-05-15
K052290	Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens	Clearlab Pte, Ltd.	LPL	Class II	2006-05-15
K052952	Cathassist	Physician Technologies, Inc.	KNY	Class II	2006-05-14
K061187	Tsx-201A, Aquilion Lb CT Scanner with Respiratory Gating	Toshiba America Medical Systems, In.C	JAK	Class II	2006-05-12
K061186	Flight	Aero Innovative Research, Inc.	IOR	Class I	2006-05-12
K060969	Polyax Locked Plating System	Depuy Orthopaedics Inc.	HRS	Class II	2006-05-12
K060479	Modification to Bodyguard Infusion Pump System	Caesarea Medical Electronics, Ltd.	FRN	Class II	2006-05-12
K060396	Ivena Vascular Patch	Atrium Medical Corporation	DXZ	Class II	2006-05-12
K060351	Medtox Oxycodone	MEDTOX Diagnostics, Inc.	DJG	Class II	2006-05-12
K060323	Ultraflex Precision Colonic Stent, Models M00557330, Mo00557360, M00557380	Boston Scientific Corporation	MQR	Class II	2006-05-12
K060116	Micrus Courier Microcatheters	Micrus Endovascular Corporation	DQO	Class II	2006-05-12
K060040	Zimmer M/l Taper Hip Prosthesis	Zimmer GmbH	LPH	Class II	2006-05-12
K053257	Para-Pro Fc50	Alpha-Tec Systems, Inc.	LKS	Class I	2006-05-12
K053191	Discon Daily (Etafilcon a) One-Day Soft (Hydrophilic) Contact Lens	Innova Vision Inc.	MVN	Class II	2006-05-12
K052690	Suretek Reprocessed Laparoscopic Instruments	Suretek Medical	NUJ	Class II	2006-05-12
K060903	Ig4 Image Guided System	Veran Medical Technologies, Inc.	JAK	Class II	2006-05-11
K060869	Rs-1000 Zoom Slitlamp with Option	Rightmedical Products, LLC	HJO	Class II	2006-05-11
K060586	Enzyme Immunoassay, Vancomycin	Roche Diagnostics GmbH	LEH	Class II	2006-05-11
K060558	Bd Phoenix Automated Microbiology System Cephalothin - Gn 1 - 64 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-05-11
K060343	Breath Alcohol Test System, Model Al-6000	Sentech Korea Corp.	DJZ	Class I	2006-05-11
K060247	Life Spine Cement Restrictor	Life Spine	JDK	Class II	2006-05-11
K060198	Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and Oscillating Saw	Linvatec Corporation	HRX	Class II	2006-05-11
K053419	Konica Minolta Pulsox-300, 300I	Konica Minolta Sensing, Inc.	DQA	Class II	2006-05-11
K053405	Bacstop	Elcam Medical A.C.A.L.	FMG	Class II	2006-05-11
K061152	Mucheck V7.0	Oncology Data Systems, Inc.	LHN	Class II	2006-05-10
K061148	Rhythmlink Disc Electrodes	Rhythmlink International, LLC	GXY	Class II	2006-05-10
K061143	Robertsite Stopcock	Halkey-Roberts Corporation	FMG	Class II	2006-05-10
K061020	Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase	Siemens Healthcare Diagnostics Inc.	CKA	Class I	2006-05-10
K061014	Actalyke Qc Kit, Models Aqc-Hp and Aqc-Lp	Helena Laboratories, Corp.	JPA	Class II	2006-05-10
K061000	Evolution Mechanical Dilator Sheath Set Models-Lr-Evn-7.0, Lr-Evn-9.0	Cook Vandergrift, Inc.	DRE	Class II	2006-05-10