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 2762 of 3530

510(k) clearances, page 2762 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875184	Unicath Lab	Xre Corp.	IZI	Class II	1988-01-29
K875066	Additional Allergens for Allerg*ens Eia Kit	Dexall Biomedical Labs, Inc.	DHB	Class II	1988-01-29
K874927	Pti Heart-Chill(tm) Cardiac Insulating Jacket	Pioneering Technologies, Inc.	DWC	Class II	1988-01-29
K874901	Revelation, Radio Fluoroscopic X-Ray Exam Table	Fischer Imaging Corp.	JAA	Class II	1988-01-29
K874813	Omed Wound Closure Strips	Oxboro Medical Intl., Inc.	FPX	Class I	1988-01-29
K874779	Bipolator 50	Treace Medical, Inc.	GEI	Class II	1988-01-29
K874728	Capillary Flow Dialyzers	Baxter Healthcare Corporation	FJI	Class II	1988-01-29
K874695	Healthdyne Apnea/heart Monitor, Model 900	Healthdyne, Inc.	DRT	Class II	1988-01-29
K874616	Moore Hip Prosthesis Fenestrated Stem	Mizuho Orthopedic Systems Inc	JDI	Class II	1988-01-29
K874599	Moore Hip Prosthesis Solid Stem	Mizuho Orthopedic Systems Inc	JDI	Class II	1988-01-29
K874571	Patientwatch (Tm)	Advanced Medical Technology, Inc.	DSH	Class II	1988-01-29
K874555	Keeler Acu 22Xt Ophthalmic Cryo Unit	Keeler Instruments, Inc.	HPS	Class II	1988-01-29
K874549	Nephross I.q. Andante	bioMerieux, Inc.	FJI	Class II	1988-01-29
K874522	Modified Myocardial Temperature Sensor	Mon-A-Therm, Inc.	KRB	Class II	1988-01-29
K874519	Modified Esophageal Stethoscope/temperature Sensor	Mon-A-Therm, Inc.	BZW	Class I	1988-01-29
K874514	Hi-Lo Temp(r) General Purpose Temperature Probe	Mallinckrodt Critical Care	FLL	Class II	1988-01-29
K874307	Model Dmc-75 Mini-Catheter Set	Life-Tech Intl., Inc.	FPA	Class II	1988-01-29
K874183	Actifix (R) Bipolar Endocardial Screw-in Lead	Daig Corp.	DTB	Class III	1988-01-29
K874037	Angio Waste Fluids Dump Bag	Procedure Products, Inc.	DQO	Class II	1988-01-29
K874020	Ultracare(tm) Automated Patient Assist Device	Abbott Medical	KPF	Class II	1988-01-29
K873954	Namic Hawkins Universal Drainage Set	North American Instrument Corp.	FGE	Class II	1988-01-29
K873546	Ves-Temp Model Vt1 Monoplace Cool/heat System	Reimers Engineering, Inc.	DWJ	Class II	1988-01-29
K873533	Siemens Sirecust 1280, 1281 W/arrhythmia Software	Medical Electronics Laboratories, Inc.	DSI	Class II	1988-01-29
K875284	Medtronic Snap Ease Model 7795 Cutaneous Electrode	Medtronic, Inc.	GXY	Class II	1988-01-28
K875224	Hudson Craninal Burrs	Tri-Med, Inc.	HBE	Class II	1988-01-28
K875054	Acromed Ads Bone Nail Driver	Buckman Co., Inc.	HWR	Class I	1988-01-28
K875041	Foam Bordered Diagnostic (Care) Electrode	Labeltape Meditect, Inc.	DRX	Class II	1988-01-28
K875018	Ghajar Guide Twist Drill	Neurodynamics, Inc.	HBG	Class II	1988-01-28
K875015	Tracets 3000	Lectec Corp.	DRX	Class II	1988-01-28
K874956	Self-Retaining Retractor for Neurosurgery	Solway, Inc.	GZT	Class II	1988-01-28
K874884	Medtronic(r) Orthoflex(tm)	Metronic, Inc.	BXB	Class I	1988-01-28
K874562	Securatrode	Meddev International Corp.	DRX	Class II	1988-01-28
K874557	Bisco Porcelain Repair Kit	Bisco, Inc.	EBC	Class II	1988-01-28
K874556	Bisco Pit and Fissure Sealant	Bisco, Inc.	EBC	Class II	1988-01-28
K874471	Super Flosser	U.S. Pacific Corp.	JES	Class I	1988-01-28
K874469	Transcutaneous Electric Nerve Stimulation (TENS)	Axelgaard Mfg. Co., Ltd.	GXY	Class II	1988-01-28
K874424	Pre-Gelled Disposable ECG Tape Electrode Hp40489e	Hewlett-Packard Co.	DRX	Class II	1988-01-28
K874423	Pre-Gelled Disposable ECG Electrode - Hp40493e	Hewlett-Packard Co.	DRX	Class II	1988-01-28
K874422	Pre-Gelled Disposable Clear Tape ECG Elec.hp13942d	Hewlett-Packard Co.	DRX	Class II	1988-01-28
K874421	Pre-Gelled Disposable ECG Electrode - Hp13941a	Hewlett-Packard Co.	DRX	Class II	1988-01-28
K874204	450Sll Defibrillator	Medical Research Laboratories, Inc.	LDD	Class II	1988-01-28
K874179	Biotis (Tm) Sabhi (Double Pour)	Otisville Biopharm, Inc.	KZI	Class I	1988-01-28
K873115	Cabot Fiber Laser Probe	Cabot Medical Corp.	HET	Class II	1988-01-28
K872866	Stand. Clear Vinyl Disposable ECG Elect.(594 Adhe)	Labeltape Meditect, Inc.	DRX	Class II	1988-01-28
K864946	Advanced Hand Held CO2 Laser/hh-550 for Doed Use	Bio Quantum Technologies, Inc.	HHR	Class II	1988-01-28
K880083	Gambro Alwall Gfe 11 & 15 Hollow Fiber Dialyzers	Gambro, Inc.	FJI	Class II	1988-01-27
K875362	Brewer Gel for Anaerobes	Fairleigh Dickinson Laboratories, Inc.	KZJ	Class I	1988-01-27
K875321	Modified Rotation Air Fluidized Bed/the Therapulse	KCI USA, Inc.	IOQ	Class II	1988-01-27
K875305	Model Uca / Spec System Uca	Spec Systems, Inc.	FZH	Class II	1988-01-27
K875275	Winthrop Pharmaceuticals Contrast Media Warmer	Sterling Drug, Inc.	JTQ	Class I	1988-01-27