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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3521 of 3526

510(k) clearances, page 3521 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760502	Valve, Anti-Syphon Model Pudenze Flush.	Joe W. Utt	JXG	Class II	1976-08-30
K760501	Valve, Standard Model Pudenze Flushing	Heyer Schulte Corp.	JXG	Class II	1976-08-30
K760487	Hemastain Phosphate Buffer	Geometric Data, Div. Smithkline Corp.	KQC	Class I	1976-08-30
K760486	Hemastain Wright Stain	Geometric Data, Div. Smithkline Corp.			1976-08-30
K760485	Hemastain Fixative	Geometric Data, Div. Smithkline Corp.	KQC	Class I	1976-08-30
K760465	Stress System, 3-Channel (#21127A)	Hewlett-Packard Co.	DPS	Class II	1976-08-30
K760464	Phon/stress System (#21126A)	Hewlett-Packard Co.	DQC	Class I	1976-08-30
K760463	Stress System, Single-Channel (#21125)	Hewlett-Packard Co.	DPS	Class II	1976-08-30
K760452	Colonoscope, 2-Channel Log (Acmi Tx-92)	American Cystocope Makers, Inc.	FDF	Class II	1976-08-30
K760451	Air Water Source (Acmi Model 710)	American Cystocope Makers, Inc.	OCX	Class II	1976-08-30
K760278	Slide, Lab-Tek Covered Micro	Miles Laboratories, Inc.	KEW	Class I	1976-08-30
K760274	Tip, Rubber, Perforated	V. Mueller O.V. Baxter Healthcare Corp.	FAJ	Class II	1976-08-30
K760177	Telescope, Rigid Endoscope	V. Mueller O.V. Baxter Healthcare Corp.	FBP	Class II	1976-08-30
K760176	Floorstand, Fiber Optic Light Source	V. Mueller O.V. Baxter Healthcare Corp.	FCW	Class II	1976-08-30
K760175	Drape, Transurethral Resection (Tur)	V. Mueller O.V. Baxter Healthcare Corp.	EYX	Class II	1976-08-30
K760174	Adapter, Resectoscope	V. Mueller O.V. Baxter Healthcare Corp.	FDC	Class II	1976-08-30
K760051	Tray, Suture Removal	M-C Ind., Inc.	KDD	Class I	1976-08-30
K760042	Blood Tubing Sets	BD Becton Dickinson Vacutainer Systems Preanalytic	KOC	Class II	1976-08-30
K760448	Syringe, CO2 Driven, Il Automatic Inject	Instrumentation Laboratory Co.	DXL	Class II	1976-08-27
K760504	Plethysmograph (Mdi System II)	Marketing Development Intl.	JOM	Class II	1976-08-26
K760466	Table, X-Ray, Rfx Classical	General Electric Co.	IXR	Class II	1976-08-26
K760461	Nose Clip	Inspiron Corp.	BXJ	Class I	1976-08-26
K760455	Obstetrical Pack (Vigilon Ob Pack)	C.R. Bard Inc	HHD	Class I	1976-08-26
K760454	Gouffon Pin, Adjustable	Howmedica Corp.	JDW	Class II	1976-08-26
K760445	Dental Prophylaxis Unit Ultrasonic	Branson Ultrasonics Corp.	ELC	Class II	1976-08-26
K760444	Photocoagulator, Log 3 Portable Xenon	Varian Assoc., Inc.	HQB	Class II	1976-08-26
K760443	Cardiac Electrode	Meadox Medicals, Div. Boston Scientific Corp.	DTB	Class III	1976-08-26
K760442	Nebulizer Adapter (Aermist)	Aerway Laboratories, Inc.	CAF	Class II	1976-08-26
K760426	Tampon, Playtex 2 Version B	Intl. Playtex, Inc.	HIL	Class II	1976-08-26
K760401	Cocaine Kit, Toxi-Pak	J.T. Baker Chemical Co.	DLN	Class II	1976-08-26
K760399	Reagent, P-Nitrophenyl Phosphate	J.T. Baker Chemical Co.	CJE	Class II	1976-08-26
K760396	Test, Macroglobulin Kit (Alpha2)	Kallestad Laboratories, Inc.			1976-08-26
K760247	Glucose Reagent Sys, Sigma Proced. 115	Sigma Chemical Co.	CFR	Class II	1976-08-26
K760233	Table, Sample Il 461	Instrumentation Laboratory Co.	JJQ	Class I	1976-08-26
K760232	Printer, Il 460	Instrumentation Laboratory Co.	JJQ	Class I	1976-08-26
K760229	Acid Base System, Radiometer Automated	The London Co.	CHL	Class II	1976-08-26
K760211	Analyzer, Glucose/urea/creatinine	Instrumentation Laboratory Co.	JJC	Class I	1976-08-26
K760151	Applicator,angiography (7310Mobin-Uddin)	Edwards Laboratories	DTK	Class II	1976-08-26
K760055	Reagent, Glucose, Flow-Through Analyzer	Smithkline Diagnostics, Inc.	CFR	Class II	1976-08-26
K760025	Ultrazyme Gt	Harleco	JPZ	Class I	1976-08-26
K760024	Ultrazyme Alkaline Phosphatase	Harleco	CJE	Class II	1976-08-26
K760023	Ultrazyme Hbd	Harleco	JMK	Class I	1976-08-26
K760429	Flouroscope, Mobile C-Arm Image Intens.	Varian Assoc., Inc.	OXO	Class II	1976-08-23
K760422	Surgical Retractor	Cutter Laboratories, Inc.	GAD	Class I	1976-08-23
K760421	Thermometer, Survalent-Electronic	Arbrook Mfg. Corp.	FLL	Class II	1976-08-23
K760420	Filter, Vacuum Line Lineguard	Diemolding Corp.	KPQ	Class II	1976-08-23
K760419	Adhesion Promotor	Lee Pharmaceuticals	EBD	Class II	1976-08-23
K760418	9075	Lee Pharmaceuticals	EBC	Class II	1976-08-23
K760417	Lee-Fill Ultraviolet-Cured Rest. Mat.	Lee Pharmaceuticals	EBF	Class II	1976-08-23
K760416	Data-Tope System Digoxin Ria	Dade, Baxter Travenol Diagnostics, Inc.	DOG	Class II	1976-08-23