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 2026-10-29, 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 2571 of 3530

510(k) clearances, page 2571 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896470	Eos Impression Trays	Ivoclar North America, Inc.	EHY	Class I	1990-02-09
K896018	Biotemp	Medadvances, Inc.	LGZ	Class II	1990-02-09
K895885	Automated Disposable Soft Tissue Biopsy Cutting	National-Standard Co.	FCI	Class II	1990-02-09
K895882	Jms Dialyzer Priming Set	JMS Co., Ltd.	KOC	Class II	1990-02-09
K895548	Conveen Intermittent Catheters	MEDLINE INDUSTRIES, LP - Northfield	KOD	Class II	1990-02-09
K895506	Flexxicon Plus Dual Lumen Dialysis Catheter	Vas-Cath, Inc.	LFJ	Class II	1990-02-09
K895420	Suction Biopsy Instrument	Mill-Rose Laboratory	FCK	Class II	1990-02-09
K895293	Kemi Labs - Adhesive Bandage Remover	Kemi Labs, Inc.	KOX	Class I	1990-02-09
K895189	Adjustable Soft Palate Lifter	Ortho Publications, Inc.	LRK	Class II	1990-02-09
K895095	Aks II	Amoco Technology Co.	LNJ	Class II	1990-02-09
K894549	Dynaphor(tm) 101, Iontophoresis Device	Henley Intl.	EGJ	Class II	1990-02-09
K891784	Bi-O.k.(tm)-Biological/chemical Indicator	Propper Mfg Co Inc	FRC	Class II	1990-02-09
K885309	Wilson-Cook Esophageal Balloon Prosthesis	Wilson-Cook Medical Inc.	ESW	Class II	1990-02-09
K884962	Addit. Indications for Bio-Cor Ext Collagen Cornea	Bausch & Lomb Pharmaceutical, Inc.	MOE	Class I	1990-02-09
K900216	Coulter Alp (Alk Phos) Reagent	Coulter Corp.	CJE	Class II	1990-02-08
K900215	Coulter Phosphorus Reagent	Coulter Corp.	CEO	Class I	1990-02-08
K896992	Metal Ureteral Basket Stone Dislodger	Annex Medical, Inc.	FFL	Class II	1990-02-08
K896901	Enzymun Test R Hcg	Boehringer Mannheim Corp.	JHI	Class II	1990-02-08
K896900	Enzymun Test R T3	Boehringer Mannheim Corp.	CDP	Class II	1990-02-08
K896804	Manifold	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-08
K896697	Pleur-Evac(r) a-6020--Infant Single Use Chest Drai	Deknatel, Inc.	KDQ	Class II	1990-02-08
K896686	Amresco Creatinine Reagent #4316100	American Research Products Co.	CGX	Class II	1990-02-08
K896650	Amylase Reagent	Sigma Chemical Co.	JFJ	Class II	1990-02-08
K896478	Luxar Model Lx-20 Minilase CO2 Laser	Luxar Corp.	GEX	Class II	1990-02-08
K896477	Nicolet Real Ear Analyzer	Nicolet Instrument Corp.	ETW	Class II	1990-02-08
K896466	Swan-Ganz Thermodilution Ejection Fraction/volume	Baxter Healthcare Corporation	DYG	Class II	1990-02-08
K896463	Resound Custom in-the Canal Hearing Aid Model Ca1	Resound Corp.	ESD	Class I	1990-02-08
K895639	Mg II Porous Total Knee System/metal-Back Patellar	Zimmer GmbH	JWH	Class II	1990-02-08
K895136	Permanent and Temp. Pacemaker Electrode & Lead Ada	Medtronic, Inc.	DTB	Class III	1990-02-08
K894543	Model 493 Ssr-3 Three Channel Solid-State Recorder	Del Mar Avionics	DSI	Class II	1990-02-08
K892380	Dade(r) Immunoassay Controls, Levels I, II, III	Baxter Healthcare Corporation	DIF	Class I	1990-02-08
K896435	Hp Sonos 500 and Sonos 1000 Ultra. Imaging System	Hewlett-Packard Co.	DPT	Class II	1990-02-07
K900007	R-100-Et Manual Collimator	Advantech Corporation	IZX	Class II	1990-02-06
K897064	Laparoscopic Access Sheath Set	Cook Ob/Gyn	HET	Class II	1990-02-06
K896886	Artec Respond Pulmonary Resuscitator	Artec Environmental Monitoring Division	BTM	Class II	1990-02-06
K896856	Mod-Ml Unicompartmental Knee Prosthesis	Osteonics Corp.	HSX	Class II	1990-02-06
K896669	Weber Permalock	Allo Pro Corp.	LZO	Class II	1990-02-06
K896611	Olympic Light-Warm	Olympic Medical Corp.	KZF	Class I	1990-02-06
K896563	Tubing Connectors	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-06
K896562	Stopcock	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-06
K896558	Yankauer Suction Tube-Rigid Type	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-06
K896557	Yankauer Suction Tube-Flexible Type	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-06
K896556	Universal Poole Suction Tube	Westmark, Sterile Packing Systems, Inc. (Sps)	GCX	Class II	1990-02-06
K896546	Homepump (Disp. Elastomeric Infusion Device)	Block Medical, Inc.	FRN	Class II	1990-02-06
K894953	Granitec P2 and Granitec G2 Dental Cements	Confi-Dental Products Co.	EMA	Class II	1990-02-06
K890328	Adult Resectoscope	Circon Video	HIH	Class II	1990-02-06
K900449	Pharmacia B2 Micro Eia	Pharmacia, Inc.	JZG	Class II	1990-02-05
K900344	Cefixime 5 Mcg Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1990-02-05
K900318	Cronex Quanta Super Rapid Sr339 Rare Earth	E.I. Dupont de Nemours & Co., Inc.	EAM	Class I	1990-02-05
K900126	Tt and Hntt by Hemochron	Accriva Diagnostics, Inc.	GJA	Class II	1990-02-05