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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2951 of 3529

510(k) clearances, page 2951 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854150	Phadirect Strep a Test	Pharmacia, Inc.	GTZ	Class I	1985-10-23
K854149	Tsk Steriject Sterile Epidural Needle	Pharmacia, Inc.	BSP	Class II	1985-10-23
K854064	Bcye (Buffered Charcoal Yeast Extract) Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	KZI	Class I	1985-10-23
K854061	Syva Mycotrans Mycoplasma Transport System	Syva Co.	JSM	Class I	1985-10-23
K854036	Manual Ventilation Accessory	Siemens Elema AB			1985-10-23
K854026	Vedlar Ventilator (Modification)	Hamilton Medical AG			1985-10-23
K853651	Cook Pacemaker 33It R Unipolar Cardiac Pulse Gener	Cook Pacemaker Corp.	DXY	Class III	1985-10-23
K853590	Cook Pacemaker Corp. 327T, Series R Unipolar Cardi	Cook Pacemaker Corp.	DXY	Class III	1985-10-23
K853402	E-Z-Guard Mouthpiece	E-Z-EM, Inc	BYP	Class I	1985-10-23
K852980	Ocs-2 Colposcope	Olympus Corp.	HEX	Class II	1985-10-23
K851901	750 Sd Ultrasound Scanner(modification)	Ultrasonix, Inc.	DXK	Class II	1985-10-23
K851889	Centurion-II, Model 3103 Apnea/brady Cardia Trachy	Clinical Data, Inc.	BZQ	Class II	1985-10-23
K851366	Companion 2800 Volume Ventilator	Medtronic, Inc.			1985-10-23
K850165	Motor Drive, Mechanical Sector Scanning-Mod417	Hoffrel Instruments, Inc.	JOP	Class II	1985-10-23
K854083	Xylene Substitute Montant	Lerner Laboratories, Inc.	KEM	Class I	1985-10-22
K854017	Entamoeba Histolytica-Positive Control(rabbit)	Lmd Laboratories	KHW	Class II	1985-10-22
K853977	Beta-Tsh-Irma	Leeco Diagnostics, Inc.	JLW	Class II	1985-10-22
K853920	Bio-Tek El 401 Handheld Microplate Washer	Bio-Tek Instruments, Inc.	JTC	Class I	1985-10-22
K853896	Gram Stain Kit	Sigma Diagnostics, Inc.	JTS	Class I	1985-10-22
K853694	Xylene Substitute	Lerner Laboratories, Inc.	KEM	Class I	1985-10-22
K853067	Fiax Test Kit for Measles-G Antibodies Flyorescent	Idt, A Division of Whittaker M.A. Bioproducts	GRE	Class I	1985-10-22
K852971	#9431 Teletrace, Telephone, EKG Transmitter	Medtronic, Inc.	DXH	Class II	1985-10-22
K852392	Edc/titan Geliso-Total Cpk Isoenzyme Procedure	Helena Laboratories, Corp.	CGS	Class II	1985-10-22
K853911	UV-a Suntanning Equipment	Eurotan Intl.	FTC	Class II	1985-10-21
K853752	Sun King	American Chase Company, Inc.	FTC	Class II	1985-10-21
K853746	Advanced Cardiovascular Systems Double Lumen Ballo	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1985-10-21
K852999	Qvantimetric 2Kappa and Lambda Test Kit	Kallestad Laboratories, Inc.	DEH	Class II	1985-10-21
K852895	Ceramic Alloy No. Dw 179	Williams Gold Refining Co., Inc.	EJH	Class II	1985-10-21
K852766	Ha-1000 & Ha-500 Hydroxylapatite Tooth Root Substi	Orthomatrix, Inc.	LYC	Class II	1985-10-21
K852407	Sensor Tape Cat. No. St-45	American Omni Medical, Inc.	DTW	Class II	1985-10-21
K854003	Sterile Soft Tissue Biopsy Needle	Co-Medical, Inc.	GEE	Class I	1985-10-18
K853980	Erosa Disposable Hypodermic Needle	Rose KG	GAA	Class I	1985-10-18
K853962	Erika Arterial Line 03-9837-0	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1985-10-18
K853945	Cui Rhinoplasty Implants	Cox-Uphuff Intl.	FZE	Class II	1985-10-18
K853860	Repair Kit Quinton Triple Lumen Right Atrial Cathe	Quinton, Inc.	DQY	Class II	1985-10-18
K853731	Hemed Needle Support Catalog No. Hap-Xxxx	Gish Biomedical, Inc.	FMI	Class II	1985-10-18
K853720	Mobile Operating Table for Orl Microsurgery	Carl Zeiss, Inc.	GDC	Class I	1985-10-18
K853200	5X2 Satalec Chiropody Case	Spelna, Inc.			1985-10-18
K852510	Computed Tomography Couch Pad for Min Analysis	Image Analysis, Inc.	KGI	Class II	1985-10-18
K852509	Qct-Bone Mineral Phantom	Image Analysis, Inc.	KGI	Class II	1985-10-18
K851575	Dr. Bruno Lnage Mini Photometer	Texas Medical Products, Inc.			1985-10-18
K844178	Model Tt25rf	Inframed, Inc.	GEX	Class II	1985-10-18
K853817	Cobe Ren New-D Dispensing Kit	Cobe Laboratories, Inc.	LIF	Class II	1985-10-17
K853744	Techna Vision, Inc.electric Table	Techna Vision	HRJ	Class I	1985-10-17
K853743	Techna Vision, Inc. Electric Chair	Techna Vision	HME	Class I	1985-10-17
K853740	Kay Plus Adult Diaper	Beghin_Say Intl., Inc.	EYQ	Class I	1985-10-17
K853701	Jelco & Cathlon IV Striped IV Catheters-Radiopagul	Critikon Company, LLC	FOZ	Class II	1985-10-17
K853536	Velcro Fistula Pressure Clamps	Cp Medical	KXM	Class II	1985-10-17
K853351	Ohmeda Heat Reflecting Patch	GE Healthcare	FMT	Class II	1985-10-17
K853287	Hubout	I M, Inc.	FPA	Class II	1985-10-17