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 2752 of 3530

510(k) clearances, page 2752 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872984	Ketac-Conditioner	Espe GmbH (US)	EMA	Class II	1988-03-09
K871744	Contatto Condoms	Razi Corp.	HIS	Class II	1988-03-09
K880464	Dynatron II	Dynatronics Laser Corp.	LBB	Class II	1988-03-08
K880115	Nutrient Gelatin	Hardy Media	JSF	Class I	1988-03-08
K880114	Nutrient Broth	Hardy Media	JSG	Class I	1988-03-08
K880024	Tampax Compak, Compact Plastic Appli. Super Plus	Tambrands Inc.	HIL	Class II	1988-03-08
K875112	Mentor B-Vat(tm) II Video Tester	Mentor O & O, Inc.	HOX	Class I	1988-03-08
K875082	O.p.c. Intravascular Catheter	Taut, Inc.	FOZ	Class II	1988-03-08
K880551	Model 439-07 and 439-09 Lifeline Myocardial Lead	Intermedics, Inc.	DTB	Class III	1988-03-07
K880349	Model 759 Custom in-the-Ear Hearing Aid	Bernafon LLC	ESD	Class I	1988-03-07
K880224	Magic Ear Model Mc Behind-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1988-03-07
K880127	Potato Dextrose Agar	Hardy Media	KZI	Class I	1988-03-07
K880068	Effervescent Denture Cleanser	Perrigo Co.	EFT	Class I	1988-03-07
K880062	C-Mate #Cmu 1001	O.R. Specialties, Inc.	HQC	Class II	1988-03-07
K880036	Bioma 5000	E.B.S., Inc.	DRG	Class II	1988-03-07
K880033	Degustar	Degussa Dental, Inc.	EJT	Class II	1988-03-07
K875298	502-US Pulse Oximeter	Criticare Systems, Inc.	DQA	Class II	1988-03-07
K875195	Ophthalmic Light Pipe Pick	Trek Medical Products, Inc.	FST	Class II	1988-03-07
K875109	Detectadot System 2000 Toxo Igg Test	Gull Laboratories, Inc.	LGD	Class II	1988-03-07
K874676	Interference Screw	Concept, Inc.	HWC	Class II	1988-03-07
K874594	Toxoplasma Igm Clin-Elisa(tm) Cat # 5560	Clinical Sciences, Inc.	LGD	Class II	1988-03-07
K874542	Toray Superselective Guidewires, Additional Types	Toray Industries (America), Inc.	DQX	Class II	1988-03-07
K874383	Mentor Plus (Condom)	Arcon Corp.	HIS	Class II	1988-03-07
K874319	Monitor, Electrographic	Medac, Inc.	DRT	Class II	1988-03-07
K873896	Simed S-100 Pulse Oximeter	Simed	DQA	Class II	1988-03-07
K873853	Disposable Infusion Cannula 0045-1/2/3 2.5/4.0/6.0	Advanced Surgical Products, Inc.	HMX	Class I	1988-03-07
K873739	Acrylic Impression Tray Materials	E&D Dental Manufacturing Co.	EBH	Class I	1988-03-07
K880649	TENS Electrode Snap Type, Disposa., Self-Adhering	Labeltape Meditect, Inc.	GXY	Class II	1988-03-04
K880613	Acco(r) Face Mask	Absorbent Cotton Co., Inc.	FXX	Class II	1988-03-04
K880571	Cath-Tech Port Implantable Vascular Access System	Catheter Technology Corp.	LJT	Class II	1988-03-04
K880450	Resusci Patient Face Shield	Laerdal Medical a/S	BTM	Class II	1988-03-04
K880413	Patellar Tendon Graft Guide	Concept, Inc.	LXH	Class I	1988-03-04
K880304	Inspiron Nebulo Basic External Heater	Intertech Resources, Inc.	CAF	Class II	1988-03-04
K880216	Model 20C W/an Ar-10A/u & Rl-20A/u for Arthroscop.	Directed Energy, Inc.	GEX	Class II	1988-03-04
K880212	Tsrh H/m Hook Holder W/rod Mover	Warsaw Orthopedic, Inc.	KWP	Class II	1988-03-04
K880211	Tsrh H/m Hook Holder	Warsaw Orthopedic, Inc.	KWP	Class II	1988-03-04
K880161	Ackrad Pediatric c.p.a.p. System	Ackrad Laboratories	BYE	Class II	1988-03-04
K880150	Pacesetter (Tm) 3500 Arthroscopic Surgical System	Dyonics, Inc.	HWE	Class I	1988-03-04
K880048	Blade, Surgical Prep Razor Straight	Crescent Corp.	LDQ		1988-03-04
K880035	Daewoo Latex Surgical Glove	California Ent.	KGO	Class I	1988-03-04
K875290	Lumbar Impaction Set	T. Korossurgical Instruments Corp.	KWP	Class II	1988-03-04
K875227	Sterile Empty Vials	Allertech, Inc.	LDH		1988-03-04
K875225	Umbilical Artery Oxygen Sensor	GE Healthcare	CCE	Class II	1988-03-04
K874825	Disposable Cauteries	Midsouth Industries, Inc.	GEI	Class II	1988-03-04
K874254	Nd:yag Surgical Laser for Pulmonary Applications	Minnesota Laser Corp.	LLO	Class II	1988-03-04
K872996	Natural-Touch (Tm) Surgeon's Glove	Hands-On Packaging, Ltd.	KGO	Class I	1988-03-04
K880717	Slide Culture Plate-Potato Dextrose Agar	Remel Inc	JSJ	Class I	1988-03-03
K880716	Slide Culture Plate-Potato Flake Agar	Remel Inc	JSJ	Class I	1988-03-03
K880680	King Systems, Breathing Bag	King Systems Corporation.	BTC	Class I	1988-03-03
K880530	Ceiling Mounted Radiographic System Traumex	Fischer Imaging Corp.	IYB	Class I	1988-03-03