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 2753 of 3530

510(k) clearances, page 2753 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880529	Ceiling Mounted Tilting Table Tangent III	Fischer Imaging Corp.	IXR	Class II	1988-03-03
K880494	Lyphochek Spinal Fluid Control (Human)	Bio-Rad	JJY	Class I	1988-03-03
K880460	Target Strep a	V-Tech, Inc.	GTZ	Class I	1988-03-03
K880388	T3 Serozyme Enzymeimmunoassay Kit, Mag Solid Phase	Serono Diagnostics, Inc.	CDP	Class II	1988-03-03
K880276	Ast (Sgot) Reagent Set	Tech-Neal Scientific, Inc.	CIT	Class II	1988-03-03
K880240	Instant Eosin-Alcoholic	Shandon, Inc.	HYB	Class I	1988-03-03
K880232	Nh Replacement Gastrostomy Kit	Biosearch Medical Products, Inc.	KNT	Class II	1988-03-03
K875213	Surecath - Itp II Percutaneous Port Access Device	Titan Medical, Inc.	LJT	Class II	1988-03-03
K875098	Ciba Corning Model 644	Ciba Corning Diagnostics Corp.	JXR	Class I	1988-03-03
K875038	Mentor Unistent Ureteral Stent Set	Mentor	FAD	Class II	1988-03-03
K874946	Shimadzu X-Ray High Voltage Generator Hd150g-60	Shimadzu Precision Instruments, Inc.	IZO	Class I	1988-03-03
K874916	Technicon Chem 1(Tm) System	Technicon Instruments Corp.	LDR	Class II	1988-03-03
K874846	Glucose (Hexokinase)	Tech-Co, Inc.	CFR	Class II	1988-03-03
K874833	Arc Adapter Assembly	Medical Equipment Development Co., Inc.	HAW	Class II	1988-03-03
K874481	Ivac(r) Volumetric Controller - Model 290	Y	LDR	Class II	1988-03-03
K872482	Gambro-Engstrom Erica IV Respirator	Gambro, Inc.	CBK	Class II	1988-03-03
K880590	Disposable Dental Probe/explorer	Baxter Healthcare Corporation	EKJ	Class I	1988-03-02
K880402	Codman Surgical Pattie	Cerenovus, Inc.	HBA	Class II	1988-03-02
K880099	Van-Tec Bladder Evacuator	Van-Tec, Inc.	KQT	Class II	1988-03-02
K880098	Van-Tec Auto Biopsy Needle	Van-Tec, Inc.	KNW	Class II	1988-03-02
K880096	Van-Tec Aspiration Biopsy System W/collection Cup	Van-Tec, Inc.	KNW	Class II	1988-03-02
K880095	Berger Prostate Culture Cytology Brush	Van-Tec, Inc.	FDX	Class II	1988-03-02
K880034	Closed Urinary Drainage Bag W/anti-Reflux & Port	Lin-Mark, Inc.	KNX	Class II	1988-03-02
K880023	Tampax Compak, Compact Plastic Appli. Regu. Tampon	Tambrands Inc.	HIL	Class II	1988-03-02
K880022	Tampax Compak, Compact Plastic Appli. Super Tampon	Tambrands Inc.	HIL	Class II	1988-03-02
K875188	Luer Lock Connectors / Ridig p.v.c.	Vas-Cath of Canada, Ltd.	LFJ	Class II	1988-03-02
K875166	Pharmaseal Sterile Umbilical Cord Clamp	Baxter Healthcare Corporation	HWI	Class I	1988-03-02
K875137	Laparoflator 3000, Standard and Electronic	F.M. Wiest USA, Inc.	HES	Class II	1988-03-02
K875126	Mic (Specific Line) Insertion Kit	Medical Innovations, Inc.	KNT	Class II	1988-03-02
K875119	Biopsy Attach. for Adms Ultrasound Probe	Advanced Diagnostic Medical Systems, Inc.	FCI	Class II	1988-03-02
K874674	Aik-100 Anesthesia Induction Kit/tray	Medical Repackers Co.	CAZ	Class II	1988-03-02
K874400	Non-Rotating Gold Cylinder and Screw	Implant Innovations International, Inc.	DZE	Class II	1988-03-02
K873989	Dopplex Ultrasonic Doppler System	Ultramed, Inc.	JOP	Class II	1988-03-02
K873521	Bronchodilator Tee - 9056 Series	Boehringer Laboratories, LLC	CAF	Class II	1988-03-02
K872588	Clearfil Photo Posterior	Kuraray Co.	EBF	Class II	1988-03-02
K871555	Rt5000 W/quanti. Spec. Doppler, Cw Dopp. Modifica.	General Electric Co.	DXK	Class II	1988-03-02
K871313	Ultra-Fresh Deodorant	Mentor	GDS	Class I	1988-03-02
K880665	Modified Group a Streptococcus Detection Kit	Allelix Diagnostics, Inc.	GTZ	Class I	1988-03-01
K880344	Iq Alkaline Phosphatase	BD Becton Dickinson Vacutainer Systems Preanalytic	CJK	Class II	1988-03-01
K880311	Wako(tm) Autokit Cholesterol	FUJIFILM Healthcare Americas Corporation	CHH	Class I	1988-03-01
K880275	Alt (Sgpt) Reagent Set	Tech-Neal Scientific, Inc.	CKA	Class I	1988-03-01
K880270	Msi-Diff Plus	Medical Specialties Inc.	JPK	Class II	1988-03-01
K880218	Binax Prolactin Irma Diagnostic Kit	Binax, Inc.	CFT	Class I	1988-03-01
K880188	Souter Strathclyde Total Elbow System	Howmedica Corp.	JDB	Class II	1988-03-01
K880175	Dade(r) Ck/ld Comprehensive Electro. Control	Baxter Healthcare Corporation	JJY	Class I	1988-03-01
K880015	Revised Labeling for Adx Cannabinoids	Abbott Medical	LDJ	Class II	1988-03-01
K880013	Revised Labeling for Adx Amphetamine/methampheta.	Abbott Medical	DKZ	Class II	1988-03-01
K880012	Revised Labeling for Adx Barbiturates	Abbott Medical	DIS	Class II	1988-03-01
K875133	Cavit-W	Espe GmbH (US)	EBG	Class II	1988-03-01
K875131	(Skd) Cholesterol Test Kit	Smithkline Diagnostics, Inc.	CHH	Class I	1988-03-01