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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2800 of 3530

510(k) clearances, page 2800 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872611	Solos Eyesite Cap Sleeve	Solos Ophthalmology	HQC	Class II	1987-08-10
K872567	Soft Contact Lens Remover	FGX International Inc.	KYE	Class I	1987-08-10
K872480	Kahn-Tact u.s.a., Eff Laryngoscope	Effner and Spreine Co.	CCW	Class I	1987-08-10
K872391	Aca Du Pont Urine Opiates (U Opi) Screen Method	E.I. Dupont de Nemours & Co., Inc.	DJG	Class II	1987-08-10
K872350	Fiberlase II Nd:yag Laser for Gastro.&urology Use	Laser Media	LNK	Class II	1987-08-10
K872038	Neb-U-Vent	Design Technologies, Inc.	CCN	Class I	1987-08-10
K871866	Medtronic Classix Models 8436/8437/8438	Medtronic, Inc.	DXY	Class III	1987-08-10
K871849	Light Cure Denture Glaze	Austenal Dental, Inc.	EBI	Class II	1987-08-10
K871789	Intecare Pediatric Urine Collector	Mercury Enterprises, Inc.	FFH	Class II	1987-08-10
K871787	Enuresis Alarm	Dilorenzo Engineering Co.	KPN	Class II	1987-08-10
K871710	Biopsy Forceps	Frantz Medical Development, Ltd.	FCL	Class I	1987-08-10
K871691	Modified Multi-Lumen Nasogastric Tube	Bissell Medical Products, Inc.	KNT	Class II	1987-08-10
K871528	Entrimit Gravity Feeding Set	Biosearch Medical Products, Inc.	KNT	Class II	1987-08-10
K871474	Part #860070 Ultrapak & #860075 Ultrapak	Medical Technical Products, Inc	HOC	Class I	1987-08-10
K871473	Part #860065 Ia Pak & Part #860060 Ia Pak	Medical Technical Products, Inc	HQC	Class II	1987-08-10
K871429	Antimicrobial Foley Catheter	American Pharmaseal Div. Ahsc	KOD	Class II	1987-08-10
K870607	Ssd-725 Ultrasound Sector Scanner	GE Medical Systems Information Technologies, Inc.	JOP	Class II	1987-08-10
K864624	Probe, Uptake, Nuclear	Carolina Medical Electronics	IZO	Class I	1987-08-10
K872878	Tri-Lock Modified Femoral Prosthesis	Depuy, Inc.	KWL	Class II	1987-08-07
K872842	Pin, Hip, Knowles	Military Engineering, Inc.	HTY	Class II	1987-08-07
K872679	Iafp T.s.a. (Tryptic Soy Agar)	I.A.F. Production, Inc.	JSG	Class I	1987-08-07
K872678	Iafp Thioglycollate W/o Indicator W/hemin&vita. K1	I.A.F. Production, Inc.	KZI	Class I	1987-08-07
K872677	Iafp B.h.i. Agar	I.A.F. Production, Inc.	JSG	Class I	1987-08-07
K872671	Iafp T.s.a. W/5% Sheep Blood	I.A.F. Production, Inc.	KZI	Class I	1987-08-07
K872668	Iafp T.s.a. W/10% Sheep Blood	I.A.F. Production, Inc.	JSG	Class I	1987-08-07
K872667	Iafp Brain Heart Infusion Broth	I.A.F. Production, Inc.	JSG	Class I	1987-08-07
K872666	Iafp K.v. Anaerobic Agar W/5% Sheep Blood	I.A.F. Production, Inc.	JSJ	Class I	1987-08-07
K872665	Iafp K.v. Anaerobic Agar	I.A.F. Production, Inc.	JSJ	Class I	1987-08-07
K872250	Lectec Stimulating Electrode	Lectec Corp.	GXY	Class II	1987-08-07
K871832	Cmv Igm Microassay	Diamedix Corp.	LKQ	Class II	1987-08-07
K871548	Captia(r) Syphilis-M	Mercia Diagnostics, Ltd.	LIP	Class II	1987-08-07
K871432	3.0 Mhz Phased Array Scanhead W/2.0 Mhz Sidearm Cw	Advanced Technology Laboratories, Inc.	ITX	Class II	1987-08-07
K870505	Optilase Yag Model 1000 Surg Laser Sys/pulmon Appl	Trimedyne, Inc.	LLO	Class II	1987-08-07
K870150	Continuous Cardiac Output Monitoring System	Cardio Metrics, Inc.	JOP	Class II	1987-08-07
K872938	Ampiciillin Sulbactam 20Mcg Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1987-08-06
K872903	Microtrak Chlamydia Tracho. Test - Methanol Fixat.	Syva Co.	LJP	Class I	1987-08-06
K872844	Thromborel S	Behring Diagnostics, Inc.	GJS	Class II	1987-08-06
K872782	Bbl(r) Gaspak CO2 Pouch(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	KZJ	Class I	1987-08-06
K872761	Cell-Dyn 610 Hematology Analyzer	Abbott Diagnostics	GKZ	Class II	1987-08-06
K872754	Health-Pak/wycombe Csr Wrap	Health-Pak, Inc.	FRG	Class II	1987-08-06
K872663	Dry-Form	Anatech, Ltd.	IFP	Class I	1987-08-06
K872625	Decalcifying Solution	Stephens Scientific	KDX	Class I	1987-08-06
K872358	Sta-Put	Design Technologies, Inc.	KMI	Class I	1987-08-06
K872195	Data-Fi Dimertest Latex Assay	American Dade	DAP	Class II	1987-08-06
K871675	Ferris Transparent Wound Dressing W/hydrocolloid	Ferris Mfg. Corp.	FRO	Unclassified	1987-08-06
K871252	Rsr Card Test	Advanced Polymer Systems, Inc.	GMQ	Class II	1987-08-06
K860688	Monoject Pharmacy Tray	Sherwood Medical Co.	FMF	Class II	1987-08-06
K872814	Shiley Therapeutic Autotransfusion System (Remote)	Shiley, Inc.	CAC	Class II	1987-08-05
K872728	Binax Irma Total Beta-Hcg Test Kit	Binax, Inc.	JHI	Class II	1987-08-05
K872727	Lh Serozyme Immunoenzymetric Assay Kit, Mag. Phase	Serono Diagnostics, Inc.	CEP	Class I	1987-08-05