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 2903 of 3529

510(k) clearances, page 2903 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860450	The Cmv-Igm Test	Microbiological Research Corp.	LKQ	Class II	1986-05-13
K860279	Cytomegalovirus Direct Fluorescent Antibody Kit	Bartels Immunodiagnostic Supplies, Inc.	LIN	Class II	1986-05-13
K855176	Transurethal Prostatome Diag Treatm Propulsion Sys	Urologic Surgical Devices Corp.	FBK	Class II	1986-05-13
K854772	Transcor (Tm) Radio-Stethoscope	K & S Medicorp	DQD	Class II	1986-05-13
K852359	Amuchina/dialyzer Disinfectant	Amuchina Intl., Inc.	FKQ	Class II	1986-05-13
K861600	Spunguard Plus Surgical Gown	Kimberly-Clark Corporation	FYA	Class II	1986-05-12
K861593	Topical Hyperbaric Oxygen Chamber	Stephenson Industries, Inc.	KPJ	Class II	1986-05-12
K861581	Centrix PCR Molar Matrix Forms (Bands)	Centrix, Inc.	DZN	Class I	1986-05-12
K861576	Shortening Osteotomy Guide	Osteotomy Guide Co.	HTH	Class I	1986-05-12
K861566	Slr Bipolar Hip Endoprosthesis	Dow Corning Wright	KWY	Class II	1986-05-12
K861560	Medipoint Multi-Sample Blood Collecting Needle	Medi Point, Inc.	FMI	Class II	1986-05-12
K861528	Tecnol Personal Shoe Cover	Technol, Inc.	FXP	Class I	1986-05-12
K861430	Churchill Injection Site	Churchill Corp.	FPA	Class II	1986-05-12
K861292	Castalert	Walgen Medical Innoventions			1986-05-12
K861100	ISO-Thermex	Columbus Instruments Intl. Corp.	FLL	Class II	1986-05-12
K860196	Oscillomate Neonatal Blood Press. Monit.-Model 901	Cas Medical Systems, Inc.	DXN	Class II	1986-05-12
K854995	Denclenz	Creighton Products Corp.	EFT	Class I	1986-05-12
K854692	Monarch II Bleaching Instrument	Almore Intl., Inc.	EEG	Class I	1986-05-12
K861743	As165 Respiration Monitor	Air-Shields, Inc.	BZQ	Class II	1986-05-09
K861720	Modified Baromed Breathing Pressure Monitor	Draeger, Inc.	CAP	Class II	1986-05-09
K861645	Micro-Tracheostomy Care Kit	Aci Medical, LLC	BTO	Class II	1986-05-09
K861630	Neurosurgical Insturments (Various)	Downs Surgical, Ltd.	HAO	Class I	1986-05-09
K861559	Series (T) Programmable Cardiac Pulse Generators	Cook Pacemaker Corp.	DXY	Class III	1986-05-09
K861438	Circuit, Anes. Breathing (Non-Rebreathing)	Vital Signs, Inc.	CAI	Class I	1986-05-09
K861418	Spinnaker	Cybermedic, Inc.	BZC	Class II	1986-05-09
K861280	Medicomp CPAP Nasal Cannula	Medicomp, Inc.	BZD	Class II	1986-05-09
K861139	Adult Tds Electrosurgical Grounding Pad (R.e.m.)	Conmedcorp	GEI	Class II	1986-05-09
K860772	Hariky, Model Gk-7	K-Mot, Inc.	GZJ	Class II	1986-05-09
K860636	Fastrace III, ECG Electrode	Andover Medical, Inc.	DPS	Class II	1986-05-09
K860124	Horizon 2000 Transcutaneous Gas Monitoring	Mennen Medical, Inc.	KLK	Class II	1986-05-09
K855238	Biotel (Tm)/uti	American Diagnostic Corp.	JMT	Class I	1986-05-09
K855107	Medtronic Model 3422A Transmitter Antenna Kit	Medtronic, Inc.	GZB	Class II	1986-05-09
K855102	Monark 869 Ergometer	Equilibrated Bio Systems, Inc.	DSP	Class II	1986-05-09
K854797	Takeda Medical Digital Sphygmomanometer, Ua-731	Takeda Medical, Inc.	DXN	Class II	1986-05-09
K854771	Saltzman Stethoscope Head	K & S Medicorp	LDE	Class I	1986-05-09
K854597	Vickers Medical Model 271 Heart Rate Monitor	Vickers, Ltd.	DRT	Class II	1986-05-09
K861678	Cot, Folding Hospital Aluminum - Manual Bed	Sierra Corp.	FNJ	Class I	1986-05-08
K861533	Sunfit, Ultra Violet Lamps and Sunlamp Products	Sunfit, Inc.	FTC	Class II	1986-05-08
K861501	Exer-Stim 2	Th Charters, Inc.	GZJ	Class II	1986-05-08
K860827	Em Stress Electrode	Electromed Intl., Ltd.	DRX	Class II	1986-05-08
K860805	Pressure Monitor Cath Models Sp5325,sp5327,sp5337	Gould, Inc.	DQO	Class II	1986-05-08
K860790	Biomecca Caretaker 1000 & 2000	Biomecca Australia, Ltd.	DPS	Class II	1986-05-08
K860652	Ultrasound Transducer #21230A 7.5Mhz Short Focus	Hewlett-Packard Co.	JOP	Class II	1986-05-08
K854610	Vascular Access Port/cath Cat.#vp-Xxxx Vasport Ser	Gish Biomedical, Inc.	DQY	Class II	1986-05-08
K854433	ECG Monitoring/defibrillation Electrode	Andover Medical, Inc.	DRX	Class II	1986-05-08
K854396	Rub E-Z	E-Z Instruments Co.	GYA	Class I	1986-05-08
K841596	Meados Intraortic Graft	Meadox Medicals, Div. Boston Scientific Corp.	DSY	Class II	1986-05-08
K861395	Emit Column Digoxin Calibrators	Syva Co.	DLJ	Class II	1986-05-07
K860586	Pha-2 Conversion Program for Platelet Analysis	Diagnostic Technology, Inc.	GKL	Class II	1986-05-07
K860427	Kontron Intra-Aortic Balloon Pump Model Kaat	Kontron Instruments, Inc.	DSP	Class II	1986-05-07