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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2908 of 3529

510(k) clearances, page 2908 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861298	Fisch Drill Irrigator	JEDMED Instrument Company	KAR	Class I	1986-04-23
K861254	Model St Hearing Aid	Fine-Tune	ESD	Class I	1986-04-23
K861200	Urotopo Catheter	Houston Biomedical, Inc.	KOD	Class II	1986-04-23
K861192	Gentle Back, Plastic Urinary Drainage Bag	Advanced Clinical Products, Inc.	KNX	Class II	1986-04-23
K861174	Shiley Silicone Dual Lumen Subclavian Cannula	Shiley, Inc.	LFJ	Class II	1986-04-23
K861153	Disposable Syringes and Hypodermic Needles	Exel Intl.	FMF	Class II	1986-04-23
K861113	Er-7C Clinical Probe Microphone	Etymotic Research, Inc.	ETW	Class II	1986-04-23
K861110	Model 366-10 Adaptaid Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1986-04-23
K861045	Model 2100 Nd:yag Surgical Laser Pulmonary Indicat	Sharplan Industries, Inc.	LLO	Class II	1986-04-23
K861030	Labor-Delivery Stretch/bed	Adel Medical, Ltd.	KNC	Class II	1986-04-23
K861009	Bipolar Cardiac Pacemaker, Model 110	Cardiac Control Systems, Inc.	DXY	Class III	1986-04-23
K860958	Catheter Introducer	Target Therapeutics	DYB	Class II	1986-04-23
K860842	Angioject	Target Therapeutics	DXT	Class II	1986-04-23
K860840	Guided Wire Torquer	Target Therapeutics	DQX	Class II	1986-04-23
K860771	Van-Tec Disposable Flexible Endoscope	Van-Tec, Inc.	GCQ	Class II	1986-04-23
K860767	Model E 600 Electrocardiograph	Kone Instruments, Inc.	DSI	Class II	1986-04-23
K860546	Dialog Programmer 700 - Program Version 6.37	Pacesetter Systems	KRG	Class III	1986-04-23
K860429	Meadox Surgimed Guide Catheter	Meadox Surgimed, Inc.	DQO	Class II	1986-04-23
K860368	Urdyn 5000 (Uroflowmeter)	Dantec Electronics, Inc.	FFO	Class I	1986-04-23
K860273	Model 525 - 25 Watt CO2 Medical Laser/podiatry	Britt Corp., Inc.	GEX	Class II	1986-04-23
K860262	Ta-6C - Part Number Slz 7520	Teledyne Avionics Div. of Teledyne	ETY	Class II	1986-04-23
K860015	Modified Cherne Cad Detector	Cherne Industries, Inc.	DXG	Class II	1986-04-23
K854757	5000 Series ECG Electrodes	Alternative Design Systems, Inc.	DRX	Class II	1986-04-23
K854591	Suprasternal Notch Dop/trans. 3Mhz	Philips North America LLC	JAF	Class II	1986-04-23
K854590	Handheld Dopler/pen Transducer 3Mhz	Philips North America LLC	JAF	Class II	1986-04-23
K854326	No Floss Flosser	Rgm Assoc.	JEQ	Class I	1986-04-23
K845004	Crib Cuddle - Infant Bed	International Purchasing Services	FMS	Class II	1986-04-23
K845003	Cuddle Carrier - Infant Bed	International Purchasing Services	FMS	Class II	1986-04-23
K845002	Cuddle Heart -Auditory/vibration Device	International Purchasing Services	FMS	Class II	1986-04-23
K861410	Lic Mobile Transport Stretchers	Lada Intl., Inc.	FPO	Class II	1986-04-22
K861015	One Time Hyperal & Catheter Dressing Change Trays	Acme United Corp.	FOZ	Class II	1986-04-22
K860694	Iv7200 and Iv7400 Infusion Pump	Medtronic, Inc.	FRN	Class II	1986-04-22
K860100	MRI Slice Thickness & Contiguity Phantom #76-902	Victoreen, Inc.	LHO	Class I	1986-04-22
K860027	Flipscreen Specific E (Pe, Se, Ne, Sw, Nw) Assay	Alerchek, Inc.	DHB	Class II	1986-04-22
K855221	Seratest RF (Hemagglutination) Kit	Hemagen Diagnostics, Inc.	DHR	Class II	1986-04-22
K855053	Thabest-Ige	Visual Diagnostics, Inc.	DHB	Class II	1986-04-22
K854953	Diamed Models 600, 900, 960, 964	Diamed Division Ill. Tool Works, Inc.	JAA	Class II	1986-04-22
K854865	Phadebas Rast Phadezym Rast Discs Fx2,fx3 & Fx5	Pharmacia, Inc.	DHB	Class II	1986-04-22
K854499	Gendex Prince 30 Medical X-Ray Generator	Gendex Corp.	IZO	Class I	1986-04-22
K854362	Modified Brain Atlas III	Bio-Logic Systems Corp.	GWE	Class II	1986-04-22
K861301	Bacti Plate (Dermatology) Product No. Ps-5000	Troy Biologicals, Inc.	JTZ	Class II	1986-04-21
K861095	Bilirubin Assay Kit (Total), Cata. Number 202-04	Diagnostic Chemicals, Ltd. (USA)	CIG	Class II	1986-04-21
K861094	Bilirubin Assay Kit (Direct), Cata. Number 202-02	Diagnostic Chemicals, Ltd. (USA)	CIG	Class II	1986-04-21
K861002	Vision Sgpt (Alt)	Abbott Medical	CKA	Class I	1986-04-21
K860891	Aivus (7000), Aspiration and Irrigation Device	Intra-Optics Labs. C/O Newman Assoc.	HQE	Class II	1986-04-21
K860794	Wrappers, Sunglasses	Mhci Corp.	HQG	Class I	1986-04-21
K860770	Am-100 I/a Ampac	Dravon Medical, Inc.	HQC	Class II	1986-04-21
K860726	Enzymatic Glucose Reagent Single Vial Glucose Oxid	Trace Scientific, Ltd.	LFR	Class II	1986-04-21
K860639	Ionized Calcium and Blood Ph Testcards	Ilex Corp.	JFP	Class II	1986-04-21
K860557	Latex R. Typhi	Health Research, Inc.	GPM	Class I	1986-04-21