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 2626 of 3530

510(k) clearances, page 2626 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893612	Two Tank Dissolution Module	National Medical Care, Medical Products Div., Inc.	FKQ	Class II	1989-07-24
K893296	Latex Examination Gloves	Midas Intl. Development Corp.	LYY	Class I	1989-07-24
K893295	Latex Examination Gloves	Lee AH Sheng Ent. Co., Ltd.	LYY	Class I	1989-07-24
K893209	Entera-Flo Spike Set	Delmed, Inc.	KNT	Class II	1989-07-24
K892575	Vinyl Patient Examination Gloves	Foodhandler, Inc.	LYZ	Class I	1989-07-24
K892440	Kendall Curity Extension Tubes	The Kendal Co.	FPA	Class II	1989-07-24
K892438	Kendall Curity Intravascular Cut Down Tubes	The Kendal Co.	FPA	Class II	1989-07-24
K892407	Modified Demand Nasal Oxygen Cannula	Salter Labs	NFB	Class II	1989-07-24
K892406	Modified Oxygen Delivery/co2 Sample Nasal Cannula	Salter Labs	CCK	Class II	1989-07-24
K892355	M1300a Ultrasound Imaging System, M1321a 3.5 Mhz	Hewlett-Packard Co.	IYO	Class II	1989-07-24
K891820	Disposable Medical Gowns	Bioshield, Inc.	FYB	Class II	1989-07-24
K891572	Angiography Custom Packs	Procedure Packs, Inc.	DTL	Class II	1989-07-24
K890093	PVC Empty Solution Container Enteral Pump Set	Kells Medical, Inc.	KNT	Class II	1989-07-24
K885243	Neovo2r Ventilatory	Halyard Health	BTM	Class II	1989-07-24
K894053	2Nd Modification of Fef(tm) End-Tidal CO2 Detector	Fenem, Inc.	CCK	Class II	1989-07-20
K893765	Gamma Glutamyl Transferase Test, Item: 65414/R1	Em Diagnostic Systems, Inc.	JQB	Class I	1989-07-20
K893752	Alanine Aminotransferase Test (Alt) Item # 65403	Em Diagnostic Systems, Inc.	CKA	Class I	1989-07-20
K893733	Centricon Concentrator	Amicon, Inc.	JJH	Class I	1989-07-20
K893690	Super Speed Potter-Bucky (Eso5-110 & 220)	Hofmann X-Ray of America, Inc.	IXQ	Class II	1989-07-20
K893689	Vision Integrated Performance Option	Siemens Medical Solutions USA, Inc.	LNH	Class II	1989-07-20
K893681	Mamm-Aire Cp	Custom Medical Products, Ltd.	IZO	Class I	1989-07-20
K893674	Rme 325R	Fischer Imaging Corp.	IZO	Class I	1989-07-20
K893673	Rms 180	Fischer Imaging Corp.	IXR	Class II	1989-07-20
K893662	J&s Iron Saturating Reagents	J.S. Medical Assoc.	JMO	Class I	1989-07-20
K893641	Cobas Fara Centrifugal Analyzer	Roche Diagnostic Systems, Inc.	JJG	Class I	1989-07-20
K893637	Mc125l-50 Shimadzu Mobile X-Ray System	Shimadzu Medical Systems	IZL	Class II	1989-07-20
K893585	14 Color Video Display 211-260-010	Mennen Medical, Inc.	LLZ	Class II	1989-07-20
K893580	Dade Lipid-Trol	Baxter Healthcare Corporation	JJY	Class I	1989-07-20
K893560	Alt Reagent (Procedure Number 159)	Sigma Chemical Co.	CKA	Class I	1989-07-20
K893409	Ysi Models 4400 & 4700 Esophageal Stethoscope Temp	Yellow Springs Instrument Co., Inc.	BZT	Class II	1989-07-20
K893269	Beckman Paragon(tm) Creatine Kinase Isoenzyme	Beckman Instruments, Inc.	CGS	Class II	1989-07-20
K893139	Document(tm) Uric Acid Linearity Test Set	Casco Standards	JIT	Class II	1989-07-20
K893007	Rep(tm) Ck-2 Stat Kit, Cat. No. 3074	Helena Laboratories, Corp.	CGS	Class II	1989-07-20
K892934	1 Video Tape Recorder Model Bk-224 H	Perkins Mfg. Co.	OXO	Class II	1989-07-20
K892929	Technicon Axon Tm System Additional Analytes	Technicon Instruments Corp.	CHJ	Class II	1989-07-20
K892875	Biad Nuclear Imaging System	Trionix Research Laboratory, Inc.	KPS	Class II	1989-07-20
K892867	Ulcercare	Jobst Institute, Inc.	DWL	Class II	1989-07-20
K892848	Pancreatic a-Amylase Pnp	Boehringer Mannheim Corp.	JFJ	Class II	1989-07-20
K892845	Software Release 1.3 for the Sl Series Linear Acce	Philips North America LLC	IYE	Class II	1989-07-20
K892668	Total Bilirubin for Manual/automated Applications	Catachem, Inc.	CIG	Class II	1989-07-20
K892500	Ciba Corning Model 570 Alliance I.s.e. Module	Ciba Corning Diagnostics Corp.	JGS	Class II	1989-07-20
K892410	Fogarty(r) Thru-Lumen Embolectomy Catheter	Baxter Healthcare Corporation	DXE	Class II	1989-07-20
K892393	Acid Phosphatase Reagent	Medical Analysis Systems, Inc.	CKB	Class II	1989-07-20
K892379	The Pouch Groin & Abdominal Stress Aid	Kuhn Industries	FSD	Class I	1989-07-20
K891762	Miniclinic Ovulation Prediction Test	Vanguard Biomedical Corp.	CEP	Class I	1989-07-20
K891050	Stat Chem System	Diagnostic Resources, Inc.	CGA	Class II	1989-07-20
K890194	Shiley Specialized Tracheostomy Tube	Shiley, Inc.	JOH	Class II	1989-07-20
K881133	70-X/rvg (Radiovisiography)	Trophy Radiologie	EHO	Class I	1989-07-20
K893042	Cathscanner(r) Intravascular Ultra Imaging System	Endosonics Corp.	IYN	Class II	1989-07-19
K892944	Interspec Transesophageal Probe Model 4515	Interspec, Inc.	JOP	Class II	1989-07-19