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 2886 of 3529

510(k) clearances, page 2886 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862452	Mx Mobile X-Ray System	Philips North America LLC	IZL	Class II	1986-07-22
K862449	Den-Mat Dentin Link	Den-Mat Corp.	EBF	Class II	1986-07-22
K862229	Phonic Ear Pe 602 Ppcs	Phonic Ear, Inc.	ESD	Class I	1986-07-22
K862169	Alpha All-in-the-Ear Hearing Aid	Authorized Hearing Systems, Inc.	ESD	Class I	1986-07-22
K862129	Set Canal Sealer Paste	Endo Technic Corp.	EKM	Class I	1986-07-22
K862093	Gingerbread Man (Tm)	Southern Pride Manufacturing, Inc.	BXB	Class I	1986-07-22
K862033	Triglycerides	Horiba Instruments Incorporated	CDT	Class I	1986-07-22
K862015	o.2 Micron Infection Resistant Hydrophobic Filter	Bipore, Inc.	FIB	Class II	1986-07-22
K861797	Allegro Intact Parathyroid Hormone Immunoassay	Nichols Institute Diagnostics	CEW	Class II	1986-07-22
K861738	Playtex Tampons	Intl. Playtex, Inc.	HIL	Class II	1986-07-22
K861644	Critikon 48-Hour Air Eliminating Filter	Critikon Company, LLC	FPB	Class II	1986-07-22
K860593	Et/rt Papillotome	Hobbs Medical, Inc.	KNS	Class II	1986-07-22
K862583	Lite Touch Gelfoam Insert	Treace Medical, Inc.			1986-07-21
K862537	Koagulab* M Coagulation System	Ortho Diagnostic Systems, Inc.	JPA	Class II	1986-07-21
K861790	Rmi Balloon-Occlusive Carotid by-Pass Shunt	Research Medical, Inc.	DWF	Class II	1986-07-21
K861363	Enzygnost Anti-Cmv Igm Test	Behring Diagnostics, Inc.	LKQ	Class II	1986-07-21
K861360	Maniquick Pedicure & Manicure Set	Quicklime Maniquick			1986-07-21
K862654	Modified Penox Lift Chair	Penox Technologies, Inc.	INO	Class II	1986-07-18
K862648	V-Bond, Paint-on Composite Restor/veneer Cement	Scientific Pharmaceuticals, Inc.	EBF	Class II	1986-07-18
K862600	Sitz Bath	W. C. Green, D.D.S.	KTC	Class I	1986-07-18
K862558	Austenal Acupac Hi Denture Base Material	Austenal Dental, Inc.	EBI	Class II	1986-07-18
K862476	Ls3000 Cannula Uterine Suction	Engineering, Inc.	HHI	Class II	1986-07-18
K862386	Ics Apolipoprotein B Reagent Test Kit	Beckman Instruments, Inc.	MSJ	Class I	1986-07-18
K862273	Betaflo 2000	Betaflo, Inc.	LDR	Class II	1986-07-18
K862162	Phonic Ear, Model Pe 1800	Phonic Ear, Inc.	ETW	Class II	1986-07-18
K862160	Camino Hand Drill - Model 030	Camino Laboratories, Inc.	HBG	Class II	1986-07-18
K862069	Cardiomet 4000 Gas Monitoring Systems	Biomedical Sensors, Inc.	DRY	Class II	1986-07-18
K862019	Ics Apolipoprotein a-1 Reagent Test Kit	Beckman Instruments, Inc.	MSJ	Class I	1986-07-18
K861994	Model Rs-3I Radiographic/fluroscopic X-Ray System	Medicor USA, Ltd.	KPR	Class II	1986-07-18
K861866	Acuson L382 and L312 Transducers	Acuson Computed Sonography	JOP	Class II	1986-07-18
K861860	Cobe Accessory Interface Module (Aim)	Cobe Laboratories, Inc.	KRL	Class II	1986-07-18
K861767	Implantable Electrode Lead, Model 030-436	Telectronics, Inc.	DTB	Class III	1986-07-18
K861544	Model 80225A Obstetrical Management System	Hewlett-Packard Co.	HGM	Class II	1986-07-18
K861534	Model 450 Infrared Imaging System	Mitek, Inc.	LHQ	Class I	1986-07-18
K861427	Entube Tm, Enteral Feeding Tube	Entech, Inc.	KNT	Class II	1986-07-18
K860975	Model 545-45 Laser for Ear, Nose & Throat	Britt Corp., Inc.	EWG	Class II	1986-07-18
K860651	Micron, Microvascular Doppler	Diagnostic Electronics Corp.	DPW	Class II	1986-07-18
K860531	Sonolayer-L, Sal-38A, with Scanner Sal-38As	Toshiba Medical Systems	ITX	Class II	1986-07-18
K860430	The Navigator Steerable Guide Wire	Meadox Surgimed, Inc.	DQX	Class II	1986-07-18
K852061	Pulsar Neurostimulator	Andromeda Research, Inc.	GZJ	Class II	1986-07-18
K862629	Surgical Laser Accessories (Sla) Case	Simpson/Basye, Inc.	FSM	Class I	1986-07-17
K862570	Dispens-O-Disc Differentiation Disks Pyr	Difco Laboratories, Inc.	JTO	Class I	1986-07-17
K862510	Stockert-Shiley Caps 4 Channel Temp. Monitor 1	Shiley, Inc.	KRI	Class I	1986-07-17
K862474	Hall Sternum Saw	Hall Surgical, Division of Zimmer, Inc.	DWH	Class I	1986-07-17
K862381	Futuremed ECG System 500	Futuremed Div. of Future Impex Corp.	DPS	Class II	1986-07-17
K861783	Disposable Stopcock	Utah Medical Products, Inc	DTL	Class II	1986-07-17
K861390	Depth Measuring Needles/vascu Implant Access Set	Baxter Healthcare Corporation	FMI	Class II	1986-07-17
K861343	R1618, R1619 & R1654 Ice Making Machines	Tri W-G, Inc.			1986-07-17
K855101	Assert Tm Biological/chemical Indicator	Surgicot, Inc.	FRC	Class II	1986-07-17
K854910	Angioflow	Angiomed U.S., Inc.	DQO	Class II	1986-07-17