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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3117 of 3528

510(k) clearances, page 3117 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K833785	Emergency Aspirator	Vitalograph, Inc.	BTA	Class II	1983-12-22
K833741	Venoset Multi Med Dual Rate Piggyback	Abbott Medical	FPA	Class II	1983-12-22
K833726	Klein Wire Tightener/bionic Wire	Bionic Instrument Corp.	HXS	Class I	1983-12-22
K833634	Emit & Methofrexate Assay	Syva Co.	LAO	Unclassified	1983-12-22
K833520	Rateminder II Specialty Care	Anatros Corp.	LDR	Class II	1983-12-22
K833448	Epos Chemistry Analyzer 5060 & 6410	EMD Millipore Corporation	JJE	Class I	1983-12-22
K833429	Peri Mirror/saliva Ejector	Dentec, Inc.	EAX	Class I	1983-12-22
K833411	Knee Prosthesis-Patella Component	Johnson & Johnson Professionals, Inc.	JWH	Class II	1983-12-22
K833353	Aclaim-Qap Ibm Personal Computer Edt	American Dade	JQP	Class I	1983-12-22
K833285	Rx IV Pentron IV	Genesis Industries, Inc.	EIS	Class I	1983-12-22
K833248	Low Profile Steerable-Intraoperative	Advanced Cardiovascular Systems, Inc.	LIT	Class II	1983-12-22
K833175	Biomet Bipolar Prosthesis	Zimmer GmbH	KWY	Class II	1983-12-22
K833139	Acute Hemodialysis Trays	Intermed, Inc.	KNZ	Class II	1983-12-22
K832877	Pre-Gelled Dispos Electrode	Advance Tech Intl.	DRX	Class II	1983-12-22
K832754	Monitoring System As100-As115 Record	Air-Shields, Inc.	DSF	Class I	1983-12-22
K832739	Stediflo Infusion Set	Dravon Medical, Inc.	LDR	Class II	1983-12-22
K832724	Actimeter Ub-103	Copal, Inc.	DRT	Class II	1983-12-22
K832713	Iri Spec Urinalysis Control	Intl. Remote Imaging Systems	JJW	Class I	1983-12-22
K832652	Oxy Monitor 5-Range Dual-Thermistor	Litton Medical Electronics	KLK	Class II	1983-12-22
K832637	Ameda Neonatal Resuscitation Unit-	Egnell, Inc.	FMT	Class II	1983-12-22
K831938	Transcutaneous Electronic Nerve Stimu	Joseph M. Piocentile	GZJ	Class II	1983-12-22
K830338	Narcotrace 80	Narco Scientific	DXN	Class II	1983-12-22
K833480	Molectron Medical Nd:yag Laser, Model 8000	Cooper Lasersonics, Inc.	LNK	Class II	1983-12-21
K830016	Vascutek Vascular Prothesis Vp1200k/50k	Pacesetter Systems	DSY	Class II	1983-12-21
K834092	Multiple Soken 3 Electron-Muscle Stim	Rehab Medical Specialties, Inc.	IPF	Class II	1983-12-20
K833376	Rianen Luteinizing Hormone Ria Kit	New England Nuclear	CEP	Class I	1983-12-20
K833288	C & B57 Pentron C & B57	Genesis Industries, Inc.	EIS	Class I	1983-12-20
K833926	Hearing Aid	Rion Acoustic Instruments, Inc.	ESD	Class I	1983-12-19
K832151	Pdm Siloxane Prosthetic Orbit	Delaware Prosthetics, Inc.	GBI	Class I	1983-12-19
K834096	Implantable Pulse Generator	Intermedics, Inc.	DXY	Class III	1983-12-16
K834085	Drager PEEP System D	Draeger, Inc.	BYE	Class II	1983-12-16
K834031	Factor II Deficient Substrate Plasma	Helena Laboratories, Corp.	GGP	Class II	1983-12-16
K833974	Aquapak 020 Humidifier Adapter	Respiratory Care, Inc.	BTT	Class II	1983-12-16
K833965	8 French Dilator 15Cm, W/luer Lock	Quinton, Inc.	DRE	Class II	1983-12-16
K833846	Process 100 St	Cgr Medical Corp.	IZO	Class I	1983-12-16
K833765	Trojan Plus II	Youngs Rubber Corp.	HIS	Class II	1983-12-16
K833760	Clostridium Difficile Ey Agar P2787	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1983-12-16
K833759	Group Strep Broth T3472 Lim	Gibco Laboratories Life Technologies, Inc.	JSD	Class I	1983-12-16
K833739	Cd-102 Carbon Dioxide Analyzer/recor	Instrumentarium Corp.	CCJ	Class II	1983-12-16
K833647	Pacemaker Sys Analyzer #384	Pacesetter Systems	KRE	Class II	1983-12-16
K833496	Oxygen Monitor/controller	Oxequip Health Ind.	CCL	Class II	1983-12-16
K833479	William Harvey H-71-5-F Cardiotomy	C.R. Bard Inc	DTN	Class II	1983-12-16
K833478	Humphrey A.d.e. System	Anaesthetic Breathing System	CAI	Class I	1983-12-16
K833385	N-Acetylprocainamide Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLG	Class I	1983-12-16
K833328	Respironics Rescue Dome	Respironics, Inc.	CAE	Class I	1983-12-16
K833322	Tubing Connectors Ec-2Xxx Series	Gish Biomedical, Inc.	DTL	Class II	1983-12-16
K833147	Centralert	Draeger, Inc.	BSZ	Class II	1983-12-16
K832516	Magnatrode Cardiac Monitoring Electrode	R2 Corp.	DRX	Class II	1983-12-16
K832421	Battery-Operated Electrocardiograph	Somatronix Research Corp.	DPS	Class II	1983-12-16
K831768	External Pulse Generator for Temp. Stim	Oscor Inc.	DTE	Class II	1983-12-16