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 2923 of 3529

510(k) clearances, page 2923 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854887	Manu/surg Inst/access Wuerzburg Tit Mini Bone Plat	Biomet Microfixation	EMH	Class I	1986-02-28
K854817	Instapure	Teledyne, Inc.	FRF	Class II	1986-02-28
K854751	Zimmer Video Products Automatic Light Source	Aspen Laboratories, Inc.	EQH	Class I	1986-02-28
K854743	2.5 Mhz Phased Array Sector Meridian Probe	Johnson & Johnson Professionals, Inc.	IYO	Class II	1986-02-28
K854626	Compumed Pulmonary Function Analyzer Model 307B	Compumed, Inc.	BZC	Class II	1986-02-28
K854581	Machida Semi-Rigid Bronchoscope Fbs-6R-50	Machida America, Inc.	EOQ	Class II	1986-02-28
K854482	Alternate Sterile Pkg Implantable Pulse Generators	Medtronic, Inc.	DXY	Class III	1986-02-28
K854372	Vm 781 Slave Scope	Nihon Kohden America Inc	DXJ	Class II	1986-02-28
K854369	Wep 7604 Telemetry Monitor	Nihon Kohden America Inc	DXH	Class II	1986-02-28
K854316	Fastens(tm)	Medical Devices Inc.	GZJ	Class II	1986-02-28
K854094	Immuchem Covalent Coat a Solid Phase Radioimmunoas	Immuchem Corp.	JLS	Class I	1986-02-28
K854013	Transtelephonic ECG Recorder/transmitter & Receive	Medrand, Inc.	DXH	Class II	1986-02-28
K853993	Dobe (Modified)	Phoenix Medical Technology, Inc.	DRX	Class II	1986-02-28
K853757	Moldtec Stimulator	Moldtec, Inc.	DRT	Class II	1986-02-28
K853178	Sibis Self Injurious Behavior Inhibiting System	Oxford Medilog, Inc.	HCB	Class II	1986-02-28
K860502	G.a.s./grieshaber Air System	Grieshaber & Co.	FRN	Class II	1986-02-27
K860444	Mazing Heat Disposable Warm Pack	Leebryan Intl.	IMD	Class I	1986-02-27
K860160	Operating Room Tray	Medical Design Concepts, Inc.	FSM	Class I	1986-02-27
K860115	Digilab Cambridge Perimeter	Bio-Rad	HOO	Class I	1986-02-27
K855231	Howmedica Bipolar Prosthesis	Howmedica Corp.	KWY	Class II	1986-02-27
K855215	Air/fluid Exchange System	Mira, Inc.	FRN	Class II	1986-02-27
K855170	Canon Non-Mydriatic Retinal Camera Cr3-45Nm	Canon Medical Components U.S.A., Inc.	HKI	Class II	1986-02-27
K854969	Cilco Sonometrics A&b Digital System (Digiscan)	Cilco, Inc.	IYO	Class II	1986-02-27
K854791	Bio-Fit Hip System	Richards Medical Co., Inc.	KWL	Class II	1986-02-27
K854476	Kalmate Model 3A	Medical Technology Systems, Inc.	GZJ	Class II	1986-02-27
K860459	Unity Disposable Incontinent Brief	Bevan Medical, Inc.	EYQ	Class I	1986-02-26
K860449	Modification Top Ultra Thinwall a-V Fistula Needle	Top Corp.	FIE	Class II	1986-02-26
K860183	Aft-Hep System	Behring Diagnostics, Inc.	DHN	Class II	1986-02-26
K860182	Model Mr-35 Holter Recorder	Oxford Medilog, Inc.	DSH	Class II	1986-02-26
K860181	Model Mr-30 Holter Recorder	Oxford Medilog, Inc.	DSH	Class II	1986-02-26
K860106	Oxygen Monitor No. Om-100, Oxygen Probe No. Op-100	American Bentley	CCE	Class II	1986-02-26
K860079	Medilog 4500 System	Oxford Medilog, Inc.	DSI	Class II	1986-02-26
K860078	Medilog 2500 System	Oxford Medilog, Inc.	DSI	Class II	1986-02-26
K855248	Blood Collecting Needle	Churchill Corp.	FMI	Class II	1986-02-26
K855145	Model:ta-Rose Resonant Overshoot Eliminator	Gould, Inc.	DRS	Class II	1986-02-26
K855139	Flexon Temporary Cardiac Conductive Multifilament	Davis & Geck, Inc.	LDF	Class II	1986-02-26
K855126	Cordis Catheter Sheath Introducers,steri-Sleeves	Cordis US Corp.	DYB	Class II	1986-02-26
K855100	S.l.t. Contact Laser System	Surgical Laser Technologies, Inc.	LNK	Class II	1986-02-26
K855067	Swank Cardiotomy Suction Line Blood Filter Ca100	Cobe Laboratories, Inc.	JOD	Class II	1986-02-26
K855066	Swank Arterial Line Blood Filter Hf6000	Cobe Laboratories, Inc.	DTM	Class II	1986-02-26
K855057	Laser Crp Kit(c-Reactive Protein Reagents)	Behring Diagnostics, Inc.	DCN	Class II	1986-02-26
K855049	Modified Model Sc4000(f) Cardiotomy Reservoir	Scimed Life Systems, Inc.	DTP	Class II	1986-02-26
K855013	Quantimetric Plus Support Pack	Kallestad Laboratories, Inc.	DEH	Class II	1986-02-26
K855012	Quantimetric Plus C4 Reagent Kit	Kallestad Laboratories, Inc.	DBI	Class II	1986-02-26
K855011	Quantimetric Plus C3 Reagent Kit	Kallestad Laboratories, Inc.	CZN	Class II	1986-02-26
K855009	Quantimetric Plus Iga Reagent Kit	Kallestad Laboratories, Inc.	CZP	Class II	1986-02-26
K855008	Quantimetric Plus Kappa Reagent Kit	Kallestad Laboratories, Inc.	DFH	Class II	1986-02-26
K855007	Quantimetric Plus Lambda Reagent Kit	Kallestad Laboratories, Inc.	DEH	Class II	1986-02-26
K854924	Ami E-Z-Pace Electode	A.M.I. Corp.	DRO	Class II	1986-02-26
K854819	CPR Slide Eiken	Syn-Kit, Inc.	DCN	Class II	1986-02-26