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 2727 of 3530

510(k) clearances, page 2727 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881306	Cmi Vacuum Delivery System #003C and #004C	Challenge Mfg., Inc.	HDB	Class II	1988-06-13
K881234	Venovalve(tm)	Abbott Medical	FPA	Class II	1988-06-13
K881215	Centrasil Silicone Elastomer Central Venous Cath	Baxter Healthcare Corporation	FOZ	Class II	1988-06-13
K880793	Light Bond	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-06-13
K880791	Maximum Cure Sealant	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-06-13
K880463	Condom (Prophylactic)	Health Technologies Intl.	HIS	Class II	1988-06-13
K873437	Bionic-Tooth-Plant Model a-1	Larry R. Ashkinazy, D.D.S.	DZE	Class II	1988-06-13
K882164	Floss Card	Arthur Blank & Co., Inc.	JES	Class I	1988-06-10
K882071	Crank Frame Retractor	Karlin Technology, Inc.	GZT	Class II	1988-06-10
K882008	Ace Screw Removal Trephine	Buckman Co., Inc.	HWE	Class I	1988-06-10
K881892	Pharmacia Ige Riact	Pharmacia, Inc.	DGC	Class II	1988-06-10
K881891	Iq Hdl Cholesterol	BD Becton Dickinson Vacutainer Systems Preanalytic	LBS	Class I	1988-06-10
K881877	Cobas Eia(tm) Photometer	Roche Diagnostic Systems, Inc.	JJQ	Class I	1988-06-10
K881855	Emit Convenience Pack: T-Uptake Assay	Syva Co.	KHQ	Class II	1988-06-10
K881827	Immunoglobulin a Test System	The Binding Site	CFQ	Class II	1988-06-10
K881773	Document(tm) Direct Ise Linearity Test Set	Casco Standards	JJR	Class I	1988-06-10
K881760	Ae1162 Clinical/diagnostic Audiometer	American Electromedics Corp.	EWO	Class II	1988-06-10
K881644	Humid-Vent 2 S	Gibeck Respiration	BYD	Class I	1988-06-10
K881506	Mamex Dc Mag Mg12	Orion Corp.	IZH	Class II	1988-06-10
K881505	Mamex Dc Mg11	Orion Corp.	IZH	Class II	1988-06-10
K881451	Simplex Universal Heated Tubing Sleeve	Simplex Medical Corp.	BZE	Class II	1988-06-10
K881444	t.e.n.s. Electrode Non-Sterile	Tens Accessories, Inc.	GXY	Class II	1988-06-10
K881428	Oxy-Cath	Pulmonary Medical Devices, Inc.	BSY	Class I	1988-06-10
K881330	Cobe Heart/lung Perfusion and Cardioplegia Pack	Cobe Laboratories, Inc.	DWF	Class II	1988-06-10
K881266	Model 9216 Respiration/heart Rate Monitor	Aequitron Medical, Inc.	BZQ	Class II	1988-06-10
K881244	Hdl Cholesterol Kit	Trace Scientific, Ltd.	LBR	Class I	1988-06-10
K881122	Updated Manual for Peds - Pulmonary Eval. & Diag.	Medical Associated Services, Inc.	BTY	Class II	1988-06-10
K880839	Ai 5200 Diagnostic Ultrasound System	Phoenix Imaging	IYO	Class II	1988-06-10
K880576	Raichem(tm) Calcium Reagent (Single Stable Liquid)	Reagents Applications, Inc.	CJY	Class II	1988-06-10
K880419	Model 800 O.b. Data Archival System	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1988-06-10
K880289	Datascope Percor Stat-Mil 9.5 Fr Intra-Aortic Ball	Datascope Corp.	DSP	Class II	1988-06-10
K880041	Velex Woven Dacron Low Porsity Vascular Graft	D-R Medical Systems, Inc.	DSY	Class II	1988-06-10
K875340	Jetpolisher(tm)	Young Dental Manufacturing Co 1, LLC.	KOJ	Class II	1988-06-10
K873764	Ambulatory Blood Pressure Monitor	Pulsetrend, Inc.	DXN	Class II	1988-06-10
K864159	Solid Phase Deter Serum Cholesterol Fr Whole Blood	Chem-Elec, Inc.	CHH	Class I	1988-06-10
K882190	S.e.a.-Port(tm) Vascular Access System	Harbor Medical Devices, Inc.	LJT	Class II	1988-06-09
K881987	Duraclean Daily Cleaner	Allergan Optical	LPN	Class II	1988-06-09
K881352	Right Atrial Catheter Insertion Tray	Quinton, Inc.	DWF	Class II	1988-06-09
K881346	Lifestat 1600 Printer	Physio Control, Inc.	DSF	Class I	1988-06-09
K881073	Shiley Femoral Cannulae Introducer Kit	Shiley, Inc.	DRE	Class II	1988-06-09
K880040	Velex Woven External Velour Dacron Graft	D-R Medical Systems, Inc.	DSY	Class II	1988-06-09
K874165	Disposable Catheter Pressure Transducer	Deseret Medical, Inc.	DXO	Class II	1988-06-09
K881801	Impres-Mb	Intl. Immunoassay Laboratories, Inc.	JHW	Class II	1988-06-08
K881774	Prolactin Mab Solid Phase Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	CFT	Class I	1988-06-08
K881355	Amerlite Hcg-60 Assay, Lan.0083/2083 240Kit/144kit	Amersham Corp.	JHI	Class II	1988-06-08
K881340	Nova Lite(tm) Autoantibody Controls	Inova Diagnostics, Inc.	LLL	Class II	1988-06-08
K881286	Tempa-Dot Clinical Thermometer Sheath	Pymah Corp.	FQZ	Class I	1988-06-08
K881174	Rid Plate Reader	The Binding Site	JZQ	Class I	1988-06-08
K880580	Extended Multipurpose Transducer Range	Pie Medical USA BV	IYO	Class II	1988-06-08
K873670	Snap Campylobactor Diagnostic Kit	Molecular Biosystems, Inc.	LQO	Class I	1988-06-08