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 2566 of 3530

510(k) clearances, page 2566 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896355	Cmv Igm Elisa Test System	Zeus Scientific LLC	LFZ	Class II	1990-02-27
K896236	Cobas Ready Bun Reagent	Roche Diagnostic Systems, Inc.	JGZ	Class II	1990-02-27
K896235	Cobas Ready Albumin Reagent	Roche Diagnostic Systems, Inc.	CIX	Class II	1990-02-27
K896232	Cobas Ready Total Bilirubin Reagent	Roche Diagnostic Systems, Inc.	CIG	Class II	1990-02-27
K896193	Tecnol Lazer(tm) Surgical Mask	Tecnol New Jersey Wound Care, Inc.	FXX	Class II	1990-02-27
K895411	Optikem Pmma Contact Lens	Optikem Polymers, Inc.	HPX	Unclassified	1990-02-27
K894248	Converter System	Mira, Inc.	HQE	Class II	1990-02-27
K890019	Latex Surgical Gloves	Argos S.A.	LYZ	Class I	1990-02-27
K900741	Biodex Back System Attachment	Biodex Corp.	IKK	Class II	1990-02-26
K900625	Mono-Plus Positive and Negative Control Set	Armkel, LLC	KTN	Class II	1990-02-26
K900620	Du Pont Mammography Cassette	E.I. Dupont de Nemours & Co., Inc.	IXA	Class II	1990-02-26
K900440	Aia-Pack Bmg	Tosoh Medics, Inc.	JZG	Class II	1990-02-26
K900367	Hofmann-Nagel (Hofna) X-Ray Tubes	Hofmann S.r.l.	ITY	Class I	1990-02-26
K900251	Rep Spe Plus-8 (Ponceau S) 3165, Plus-8 No. 3175	Helena Laboratories, Corp.	CEF	Class I	1990-02-26
K900234	Pfm-90 Ceiling Tube Support	Fischer Imaging Corp.	IYB	Class I	1990-02-26
K900233	Tct-300S - Upgrade	Toshiba America Medical Systems, In.C	JAK	Class II	1990-02-26
K897150	Lipase Color [Toyo] Serum Lipase Test Kit	Toyo Jozo Co., Ltd.	CHI	Class I	1990-02-26
K897026	Canyon Medical Femoral Bypass Cannulae and Intro.	Canyon Medical Products	DWF	Class II	1990-02-26
K896951	Satellite G Blood Glucose Monitoring System	Medisense, Inc.	CGA	Class II	1990-02-26
K896907	3M IV Flow Regulator	3M Company	LDR	Class II	1990-02-26
K896885	Disposable Respirtory Kit (Mp-200)	Medipart Jerry Alexander	IYT	Class II	1990-02-26
K896875	Positive and Negative Hcg Serum Controls	Armkel, LLC	JJX	Class I	1990-02-26
K896806	Catheter Plug/protector	Westmark, Sterile Packing Systems, Inc. (Sps)	KNY	Class II	1990-02-26
K896772	EKG, ECG Kenz, ECG 303	Cambridge Medical Instruments, Inc.	DPS	Class II	1990-02-26
K896771	EKG, ECG Kenz, ECG 302	Cambridge Medical Instruments, Inc.	DSI	Class II	1990-02-26
K896764	Universal Connector Catalog No. 48-1025-5	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-26
K896763	Catheter Adapter Co-Pak Catalog No. 48-0122-1	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-26
K896761	Transfer Set Sealing Cap, Cat. No. 48-1027-1	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-26
K896740	Axial and Offset Crosslink Plates	Danek Medical, Inc.	KWP	Class II	1990-02-26
K896726	4 Sure External Male Catheter	The Boston & Pacific Co., Inc.	KOD	Class II	1990-02-26
K896703	Tbd Iontophoresis Electrode	Empi	EGJ	Class II	1990-02-26
K896373	1400 Series Evidence Collection Kit	Transidyne General Corp.	GIM	Class II	1990-02-26
K896097	Vidas Respiratory Syncytial Virus (Rsv) Assay	Vitek Systems, Inc.	GQG	Class I	1990-02-26
K896005	Small Catheter Inflator	Allied Systems Co.	MAV	Class II	1990-02-26
K895688	Nobles-Lai Engineering Infusion Pump	Nobles-Lai Engineering, Inc.	DQI	Class II	1990-02-26
K895379	Low Energy Dc - Defibrillator (Including Paddles)	Physio Control, Inc.	LDD	Class II	1990-02-26
K895044	Dual Guide Introducer Catheter	Cook Inc.	DYB	Class II	1990-02-26
K900617	Seratest Ena [Ssa] Kit	Hemagen Diagnostics, Inc.	LLL	Class II	1990-02-23
K900586	Medrad Fluorovision Hr 2000, High Resolution Image	Medrad, Inc.	LLZ	Class II	1990-02-23
K900498	Modified Betatron IV Insulin Infusion System	Cardiac Pacemakers, Inc.	LZG	Class II	1990-02-23
K900372	Biotrack Immunochemistry Monitor	Biotrack, Inc.	JJQ	Class I	1990-02-23
K897169	Quikread(r) Whole Blood Triglyceride Test Kit	Photec Diagnostics, Inc.	CDT	Class I	1990-02-23
K897166	Coulter Total Protein Reagent	Coulter Electronics, Inc.	CEK	Class II	1990-02-23
K897165	Coulter Ast (Got) Reagent	Coulter Electronics, Inc.	CIT	Class II	1990-02-23
K897098	Siemens Endo-P-Probe	Siemens Medical Solutions USA, Inc.	ITX	Class II	1990-02-23
K896954	Abbott Spectrum Uric Acid Reagent Kit	Abbott Medical	KNK	Class I	1990-02-23
K896948	Alpha-Stim Cs	Electromedical Products, Inc.	GZJ	Class II	1990-02-23
K896867	Thyroid Stimulating Hormone-Eia-Xt	In Vitro Diagnostics, Inc.	JLW	Class II	1990-02-23
K896834	Model Bt-1 Fot Bolt Installation Kit	Pearl Instruments Corp.	GWM	Class II	1990-02-23
K896829	Technicon Ra Systems Sodium (Colorimetric Method)	Technicon Instruments Corp.	JGT	Class II	1990-02-23