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 2026-10-29, 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 2675 of 3530

510(k) clearances, page 2675 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884848	Basic Biofeedback,tmg4.1, Sa1/2, Eeg4/5, Ir Receiv	Moe	HCC	Class II	1989-02-02
K884816	Access(tm) Magnetic Resonance Device Accessory	Diasonics, Inc.	LNH	Class II	1989-02-02
K884794	Progesterone Serozyme Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	JLS	Class I	1989-02-02
K884742	Escort Non-Invasive Blood Pressure Option	Medical Data Electronics	DXN	Class II	1989-02-02
K884662	Patient Monitor Model 703	Ivy Biomedical Systems, Inc.	DPS	Class II	1989-02-02
K884645	Patient Monitor Rigel Model Multicare 429	Rigel Medical Electronics, Inc.	DRT	Class II	1989-02-02
K884619	Pach-Pen Calculator	Oculab, Inc.	DXG	Class II	1989-02-02
K884617	Ortho Result Plus/rubella Rapid Color. Immunoassay	Ortho Diagnostic Systems, Inc.	LFX	Class II	1989-02-02
K884546	Creatine Kinase Test (Ck) Item Number: 65661	Em Diagnostic Systems, Inc.	CGS	Class II	1989-02-02
K884091	Sourcerer	John Caunt Scientific, Ltd.	JJJ	Class I	1989-02-02
K882262	Glucose-Super Fast 4983050 and 4983500	American Research Products Co.	CGA	Class II	1989-02-02
K885016	Coi 24 Hr Collagen Shield	Chiron Ophthalmics	MOE	Class I	1989-02-01
K885005	Microvasive Gold Probe	Boston Scientific Corporation	KNS	Class II	1989-02-01
K884701	Cath-Finder System	Pharmacia Deltec, Inc.	FOZ	Class II	1989-02-01
K884624	Mvl/modulab with Pvr Module	Life Sciences Manufacturing, Inc.	JOM	Class II	1989-02-01
K884614	Edentec Model 2000W Option S Cardio-Resp. Process.	Edentec Corp.	DQA	Class II	1989-02-01
K884338	Lacey Posterior Stabilized Knee System	Dow Corning Wright	JWH	Class II	1989-02-01
K881857	Amnicath(tm) Model Dt-Iupc Trans. Tipped Intrau.	Spectramed, LLC	KXO	Class II	1989-02-01
K890308	Hydrotone I	Hydrotonics Therapy Corp.	ILJ	Class II	1989-01-31
K890150	H-3000 Oxygen Concentrator	Healthdyne, Inc.	CAW	Class II	1989-01-31
K890082	Dispensing Pin/chemotherapy Dispensing Pin	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1989-01-31
K890025	Quik-Dot Antistreptolysin-O	Ampcor, Inc.	GTQ	Class I	1989-01-31
K885264	Winged Infusion Set	E-Z-EM, Inc	FPA	Class II	1989-01-31
K885202	16 Long Catheter W/adapter, 14 Fr and 12 Fr	Coeur Laboratories, Inc.	KOD	Class II	1989-01-31
K885167	Trudell Bent Catheter	Sil-Med Corp.	FJS	Class II	1989-01-31
K884924	Visi-Wipe	Visitec Co.	HOF	Class I	1989-01-31
K884611	The Orthoranger II Electronic Goniometer	Medical Instruments Technology, Inc.	KQX	Class I	1989-01-31
K884554	Peritoneal Catheter Stabilization Device 5C4381	Baxter Healthcare Corporation	FKX	Class II	1989-01-31
K884102	Modified 7 Inch Continuous Infusion Sets	Quinton, Inc.	FPA	Class II	1989-01-31
K883805	Rocket Sex Crime Kit	A & A Medical, Inc.	FMC	Class I	1989-01-31
K883748	Renak-E & Renek-a Series Hollow Fiber Dialyzers	Kawasumi Laboratories Co., Ltd.	FJI	Class II	1989-01-31
K882999	Rubenostika(tm) Igm Microelisa System	bioMerieux, Inc.	LFX	Class II	1989-01-31
K882714	Urinary Drain Bag, Lsl Cat. No. 1425 and 1450	Lsl Industries, Inc.	EYZ	Class I	1989-01-31
K882544	Cuddle Up Pillow	Ohio Medical Instrument Co., Inc.	FRP	Class I	1989-01-31
K890045	Model 6208,6209,6210,6211,6212,6214 (Pli's)	Medtronic, Inc.	DTB	Class III	1989-01-30
K885347	Vitacomm Model #140/141 Esophageal Stethoscope	Vitacomm, Inc.	BZT	Class II	1989-01-30
K885285	Direct Bilirubin Test Catalog No. Sr1008	Em Diagnostic Systems, Inc.	CIG	Class II	1989-01-30
K885284	Total Bilirubin Test Catalog No. Sr1007	Em Diagnostic Systems, Inc.	CIG	Class II	1989-01-30
K885273	Micro Surgical Instrument System	Tava Surgical Instruments	HSZ	Class I	1989-01-30
K885053	Biotrol Urine Proteins Reagent	Biotrol, USA, Inc.	JIR	Class I	1989-01-30
K885041	Biotrol Inorganic Phosphorus	Biotrol, USA, Inc.	CEO	Class I	1989-01-30
K884893	Cardiotomy Reservoir Valve No. Crv-30 or Pcrv-25	American Omni Medical, Inc.	KRI	Class I	1989-01-30
K884872	Dideco-Shiley Autotransfusion Cardiotomy Reservoir	Shiley, Inc.	DTN	Class II	1989-01-30
K884865	Permaseal and Denture Seal	American Mfg., Inc.	EBI	Class II	1989-01-30
K884856	Aptt Reagent	Precision Biologicals, Inc.	GFO	Class II	1989-01-30
K884855	Thromboplastin	Precision Biologicals, Inc.	GJS	Class II	1989-01-30
K884854	Coagulation Control Plasma (Normal & Abnormal)	Precision Biologicals, Inc.	GGN	Class II	1989-01-30
K884827	Kodak Dental Barrier Pac	Eastman Kodak Company	IWZ	Class I	1989-01-30
K884792	Vascular Access Port Huber Point Infusion Needles	Infucare Products, Inc.	FMI	Class II	1989-01-30
K884748	Technicon Chem 1 System Acid Phos (Prostatic)	Technicon Instruments Corp.	JFH	Class II	1989-01-30