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 2743 of 3530

510(k) clearances, page 2743 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874788	Ketac-Bond Aplicap	Espe GmbH (US)	EMA	Class II	1988-04-12
K873604	E.w.l. P-Tens/h-Wave for General Dentistry	Electronic Waveform Laboratory, Inc.	LWM	Unclassified	1988-04-12
K873294	Biotrol Toxo Elisa Test G	Biotrol, USA, Inc.	LGD	Class II	1988-04-12
K873293	Biotrol Toxo Elisa Test M	Biotrol, USA, Inc.	LGD	Class II	1988-04-12
K871267	Blausiegel Transparent Condoms	Ticosan, Inc.	HIS	Class II	1988-04-12
K881424	Premier 10S (TENS)	American Imex	GZJ	Class II	1988-04-11
K881399	3 French Flexible Biopsy Forceps	Cook Incorporated	OCZ	Class II	1988-04-11
K881176	Sterile Esmarch Bandage	Spectrum/Hydro-Med Products, Inc.	GAX	Class I	1988-04-11
K881085	Soft-E Series T-10 Accutrace Tab Resting Electrode	Contour Electrodes, Inc.	DRX	Class II	1988-04-11
K880980	Schuldt* Pc* - Dual Channel TENS	Schuldt Laboratories, Inc.	GZJ	Class II	1988-04-11
K880969	Star 22,33,66 Series & Starkey H. and Sm Series	Starkey Laboratories, Inc.	ESD	Class I	1988-04-11
K880882	Reverse Curve Archwire	Flexmedics	EJF	Class I	1988-04-11
K880637	Baxter, Pharmaseal Patient Gas Sampling Lines	Baxter Healthcare Corporation	BZO	Class I	1988-04-11
K880626	King of Hearts	Instromedix, Inc.	DXH	Class II	1988-04-11
K880326	Maestro(r) Models 115, 118, 215 and 218 Pacemakers	Cardiac Control Systems, Inc.	DXY	Class III	1988-04-11
K880171	Model 4900 Nd:yag Laser for Gastro & Genitour Appl	Cooper Lasersonics, Inc.	LNK	Class II	1988-04-11
K880092	Resubmitted Fitness Upper Body Ergometer #5100	Invacare GmbH	BXB	Class I	1988-04-11
K880047	Huestis Compu-Former	Huestis Machine Corp.	IXI	Class II	1988-04-11
K874679	Tracheal Tube Laser Shield Kit	Americal Corp.	BTR	Class II	1988-04-11
K871868	Venti-Scan II	Atomic Products Corp.	IYT	Class II	1988-04-11
K881394	Non-Sterile Suture Needles	China National Medicines C/O Havel'S	GDL	Class I	1988-04-08
K881372	Endicott & Beaman Supra-Tec Face Mask	Endicott & Beaman, Inc.	FXX	Class II	1988-04-08
K881144	Yesng Patient Plate #80226	Ferguson Medical	JOS	Class II	1988-04-08
K881024	Archgauge(tm)	Archxerciser Corp.	IPF	Class II	1988-04-08
K880235	Intelect Model 120	Chattanooga Group, Inc.	IPF	Class II	1988-04-08
K874137	Modified Biologic 1000 Hemodial. & Hd-1000 Dis Car	Ash Medical Systems, Inc.	FKT	Class II	1988-04-08
K871867	Elite Modular Hip System	Thackray USA	JDI	Class II	1988-04-08
K881292	Allen Lateral Armboard	Edgewater Medical Systems, Inc.	BTX	Class I	1988-04-07
K881247	Mono-Phile	Bio Diagnostic Systems, Inc.	KTN	Class II	1988-04-07
K881163	Rectangular Nitinol Arch Wire	Flexmedics	EJF	Class I	1988-04-07
K881139	Thermafil Endodontic Obturator	Tulsa Dental Products LLC	EKM	Class I	1988-04-07
K881083	General Purpose Kit	Med-Dex Intl.	LRO	Class II	1988-04-07
K880875	Vitallium Equipoise Alloy	Austenal Dental, Inc.	EJH	Class II	1988-04-07
K880392	Ortholux Visible Light Curing Unit	Unitek Corp.	EBZ	Class II	1988-04-07
K880356	N Protein Standard Plasma (Human)	Behring Diagnostics, Inc.	CFN	Class II	1988-04-07
K875346	Autolyzer 801 System (Automated Cell Counter)	Contraves Medical Instruments, Inc.	GKZ	Class II	1988-04-07
K875329	Ivt Central Allergy Screen	In Vitro Technologies, Inc.	DHB	Class II	1988-04-07
K873845	Sim 4000I	Ote-Biomedica Elettronica S.P.A	IYO	Class II	1988-04-07
K881353	Mti Wolff System	Health Systems Intl., Inc.	LEJ	Class II	1988-04-06
K881181	Nova Gel(tm) Sm/rnp	Inova Diagnostics, Inc.	LLL	Class II	1988-04-06
K881160	Crank Frame Retractor	T. Korossurgical Instruments Corp.	GZT	Class II	1988-04-06
K881157	Sternum Spreader and Mitral Valve Retractor	T. Korossurgical Instruments Corp.	GAD	Class I	1988-04-06
K881151	Microscrape	Ortho Pharmaceutical Corp.	LXK	Class I	1988-04-06
K881126	Qm300 Albumin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DCF	Class II	1988-04-06
K881101	K Orthopedic Table	Instrumentation Specialties, Inc.	JEB	Class I	1988-04-06
K881095	Koi(tm) Instrument Trays	CooperVision, Inc.	LRP	Class I	1988-04-06
K880751	Ultima Xs (TENS)	American Imex	GZJ	Class II	1988-04-06
K880648	Endoscopic Elastic Band Ligator	Superior Healthcare Group, Inc.	FHN	Class II	1988-04-06
K880593	Teca/medelec Mistral	Teca, Inc.	GWE	Class II	1988-04-06
K880537	Pole, Intravenous	Ferguson Medical	FOX	Class I	1988-04-06