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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1949 of 3531

510(k) clearances, page 1949 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962726	Bard Quantum Cvr	C.R. Bard Inc	DTP	Class II	1996-10-30
K954850	Bard William Harvey HF-6000 Membrane Oxygenator	C.R. Bard Inc	DTZ	Class II	1996-10-30
K963797	Pm Synthetic Medical Gloves, Powder Free	Shanghai PM Plastics Enterise Co., Ltd.	LYZ	Class I	1996-10-29
K963751	Pt Synthetic Medical Gloves, Powder Free	Shanghai PT Plastics Enterprise Company, Ltd.	LYZ	Class I	1996-10-29
K963533	Sigma Diagnostic Cx -3 Calibration Standard Level 1	Sigma Diagnostics, Inc.	JIX	Class II	1996-10-29
K963528	Alimed Positioning 7 Safety Straps (Three Types), Universal Cr/mri Wide Body Strap, Universal CT Scanner Strap (2 Sizes)	Alimed, LLC	FMQ	Class I	1996-10-29
K963504	Medline Open End Finger Control Mitt	Medline	FMQ	Class I	1996-10-29
K963378	Medline Economy Limb Holder,deluxe Limb Holder,cinch-Type Limb Holder,padded Limb Holder,adjustable Limb Holder	MEDLINE INDUSTRIES, LP - Northfield	FMQ	Class I	1996-10-29
K963306	Cedia N-Acetylprocainamide Assay	Boehringer Mannheim Corp.	LAR	Class II	1996-10-29
K963205	Alginmax, Orthochrome	American Tooth Industries	ELW	Class II	1996-10-29
K963144	Gc Baseline	GC America Inc.	EBI	Class II	1996-10-29
K962892	Helax Tms Brachytherapy, Version 3.0	Siemens Medical Solutions USA, Inc.	LNH	Class II	1996-10-29
K962859	Mini Sample Processor	Cavro Scientific Instruments, Inc.	JQW	Class I	1996-10-29
K962724	Sterile Latex Surgical, Sold Under Brand Names Savacare and Rogumed	Sonnheim Medikal GmbH	KGO	Class I	1996-10-29
K962292	Hearsaver	Emtech Laboratories	EWD	Unclassified	1996-10-29
K962269	Cedia Cardiac Tdm Multi-Cals	Boehringer Mannheim Corp.	JIX	Class II	1996-10-29
K962178	Bard Tiger Guidewire Model 000540	C.R. Bard Inc	OCY	Class II	1996-10-29
K962158	Pico Models 30, 50, 70	Radiometer America, Inc	JKA	Class II	1996-10-29
K961833	Sonoline Elegra with Siescape Feature	Siemens Medical Solutions USA, Inc.	IYO	Class II	1996-10-29
K961598	Els Automatic Tubing Clamp System	Rocky Mountain Research, Inc.	KRL	Class II	1996-10-29
K961595	Defibrillator Analyzer, Delta 1000	Netech Corp.	DRL	Class II	1996-10-29
K960431	Pressure Stopcock/manifold	Scientific Device Manufacturer, LLC	FPA	Class II	1996-10-29
K963822	Ovation Agc-3	Orsonique, Inc.	ESD	Class I	1996-10-28
K963821	Ovation Agc-1	Orsonique, Inc.	ESD	Class I	1996-10-28
K963820	Ovation Linear	Orsonique, Inc.	ESD	Class I	1996-10-28
K963819	Ovation Asp	Orsonique, Inc.	ESD	Class I	1996-10-28
K963818	Ovation Agc-2	Orsonique, Inc.	ESD	Class I	1996-10-28
K963740	Leibinger - Luhr Small Mandibular Bone Screws	Howmedica Leibinger, Inc.	JEY	Class II	1996-10-28
K963526	Strap Wedge	Alimed, LLC	FMQ	Class I	1996-10-28
K963287	Vacuum Cup (004Sd)	Swift Delivery Products	HDB	Class II	1996-10-28
K963219	Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and Sponges	Fci Ophthalmics, Inc.	HQX	Class II	1996-10-28
K963026	Tbd	Acu Med, Inc.	HSB	Class II	1996-10-28
K962967	Fuji Medical Dry Imager Fm-Dp 2636	FUJIFILM Healthcare Americas Corporation	LMC	Class II	1996-10-28
K962955	Gammacon Image Translation System	Medical Imaging Technology Assoc., Inc.	KPS	Class II	1996-10-28
K962714	Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number Pmv 2000 or Pmtsv 2000	Passy-Muir, Inc.	JOH	Class II	1996-10-28
K962190	Patellofemoral Joint Prosthesis	Intermedics Orthopedics	KRR	Class II	1996-10-28
K961677	Acupuncture Needles	K.S. Choi Corp.	MQX	Class II	1996-10-28
K961432	Radias Galt Test	Bio-Rad	JJX	Class I	1996-10-28
K961426	Bio Boost	Bio Compression Systems, Inc.	IRP	Class II	1996-10-28
K961425	Bio Compression Cold Flo, Single Chamber Intermittent and Multi-Chamber Sequential Models	Bio Compression Systems, Inc.	ILO	Class II	1996-10-28
K961341	Convertors Polyolefin Fabric Gowns	Baxter Healthcare Corporation	FYA	Class II	1996-10-28
K961054	Sysmex Uf-100	Sysmex Corporation	LKM	Class II	1996-10-28
K960968	Medi-Trace 200, Medi-Trace 200-30	Graphic Controls Corp.	DRX	Class II	1996-10-28
K960299	Pyramid Trocar, 10Mm W/spring Ret. Protective Sleeve or Trocar W/spring Loaded Protection Sleeve	Richard Wolf Medical Instruments Corp.	HET	Class II	1996-10-28
K954788	Eureduc Pneumatic Drainage System	Eureduc	JOW	Class II	1996-10-28
K954448	Viotec V-2200 Ultraviolet Germicidal Air Purification System	Schiff & Co.	FRA	Class II	1996-10-28
K963845	Meropenem, 10 Mcg, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1996-10-25
K963623	Spyroflex Pigmented Wound Dressing	Polymedica Industries, Inc.	MGP	Unclassified	1996-10-25
K963619	Gore-Tex Soft Tissue Patch,mycromesha Biomaterial,dualmesh Biomaterial,dualmesh Biomaterial with Holes	W. L. Gore & Associates, Inc.	FTL	Class II	1996-10-25
K963395	Imageserver 2000 Picture Archiving System	Sectra-Imtec AB	LMB	Class I	1996-10-25