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 2893 of 3529

510(k) clearances, page 2893 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862043	Delfia (Tm) Hfsh Kit	Lkb Instruments, Inc.	CGJ	Class I	1986-06-24
K854963	S80 Implantable Cardiac Pacing Lead	Sorin Biomedica, Fiat, USA, Inc.	DTB	Class III	1986-06-24
K862284	Sealite	Sybron Corp.	EBC	Class II	1986-06-23
K862280	Shofu Lining Cement	Shofu Dental Corp.	EMA	Class II	1986-06-23
K862212	Lifecare Remote Alarm #34-001	Lifecare Services, Inc.	CBK	Class II	1986-06-23
K862104	Model Uc Spectrum in-the-Canal Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862103	Model Uc in-the-Canal Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862102	Model Km in-the-Canal Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862101	Model Um in-the-Canal Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862100	Model Ed Behind-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862099	Dahlberg Model Ee Behind-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-06-23
K862050	Lifesound Custom Ite	Lifesounds, Inc.	ESD	Class I	1986-06-23
K862036	Model Hp Hearing Aid	Fine-Tune	ESD	Class I	1986-06-23
K862021	Phacoemulsification Ultrasonic Fragment System	Ultramed, Inc.	HQC	Class II	1986-06-23
K861939	Model Pc Hearing Aid	Fine-Tune	ESD	Class I	1986-06-23
K861487	St-90 Spiro Analizer	Future Impex Corp.	BTY	Class II	1986-06-23
K861388	Sarns Portable Power Module	3M Health Care, Sarns	DTQ	Class II	1986-06-23
K861209	Stream-Switch Manifold	Intelligent Medicine, Inc.	FRN	Class II	1986-06-23
K861190	Ptt Automate Test Kit	American Bioproducts Co.	GGW	Class II	1986-06-23
K861147	Ucs-2, Ultrasonic Cleaning Solution	Keymed, Inc.	FLG	Class I	1986-06-23
K861040	Enternal Infuser Multipump 203	Medix Medical Electronics (U.S.A.), Inc.	FRN	Class II	1986-06-23
K862263	Persunal Tan, Model No. Hu-0208L	Sunthetic Engineering, Inc.	FTC	Class II	1986-06-20
K862175	White Oak Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-06-20
K861903	#6000 Nd:yag Laser System Urology/gastrointestinal	Cooper Lasersonics, Inc.	LNK	Class II	1986-06-20
K861499	Biostar* Reads* Immune Complex Assay Kit	Biostar Medical Products, Inc.	DAK	Class II	1986-06-20
K854813	Mednova Blood Pressure Cuff	Mednova Corp.	DXQ	Class II	1986-06-20
K854473	Portalase 300 Carbon Dioxide Surg Laser Neurologic	Minnesota Laser Corp.	GEX	Class II	1986-06-20
K854468	Portalase 200 Carbon Dioxide Surg Laser Neurologic	Minnesota Laser Corp.	GEX	Class II	1986-06-20
K854337	Sdl-300	Shimadzu Corp.	ITX	Class II	1986-06-20
K862197	Rmp Compant Cricothyrotomy Equipment Storage Tray	Rmp Co.			1986-06-19
K862172	Quali-Med's Operating Room Drapes	Quali-Med, Inc.	KKX	Class II	1986-06-19
K862149	Modified Neuromuscular Transmission Monitor	Medtronic, Inc.	BXN	Class II	1986-06-19
K862132	Hci Meconium Aspirator	Hospital Concepts, Inc.	BSY	Class I	1986-06-19
K862126	Sterile Laparotomy Gauze Sponge	Anago, Inc.	EFQ	Unclassified	1986-06-19
K862113	No. 100352 Galvanic Oxygen Sensor	Vascular Technology Incorporated	CCL	Class II	1986-06-19
K862094	Lens-Eze	Insight International, Inc.	HJK	Class II	1986-06-19
K862064	Entravision Ep-500 I/a Ecco Pack	Entravision, Inc.	HQC	Class II	1986-06-19
K862063	Entravision Modeco II I/a Machine & I/a Handpiece	Entravision, Inc.	HQC	Class II	1986-06-19
K862048	Suds(hcg)control Set (Urine&serum) & Hcg Ref.serum	Murex Corp.	DQX	Class II	1986-06-19
K862046	Swan-Neck Peritoneal Dialysis Catheters	Accurate Surgical Instruments Co.	FJS	Class II	1986-06-19
K862022	Lic-Orthion Multi-Therapy Treatment Table	Lic-Orthion	JFB	Class II	1986-06-19
K862014	Immpulse Ferritin Assay Reagent	Sclavo, Inc.	DBF	Class II	1986-06-19
K861995	Model Rs-3 Radiographic Stand	Medicor USA, Ltd.	IYB	Class I	1986-06-19
K861951	Modified Teleflex Medical Introducer Catheter	Teleflex Medical	DYB	Class II	1986-06-19
K861776	High Efficiency Hemodialysis System	Travenol Laboratories, S.A.	KDI	Class II	1986-06-19
K861707	Master Program Flow & Pressure CO2 & Lung Monitor	Siemens Elema AB	CBK	Class II	1986-06-19
K861648	Wise Iridotomy-Spincterotomy Lens	Ocular Instruments, Inc.	HJK	Class II	1986-06-19
K861595	Ball Electrodes	National Wire & Stamping, Inc.	GEI	Class II	1986-06-19
K861594	Electrosurgical Needle Electrode (Solid Type)	National Wire & Stamping, Inc.	GEI	Class II	1986-06-19
K861577	Acuson S228, S519 & L558 Transducers	Acuson Computed Sonography	HGL	Class II	1986-06-19