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 2026-10-29, 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 2690 of 3530

510(k) clearances, page 2690 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883866	Neosoft Umbilical Vessel Catheter	Menlo Care, Inc.	FOZ	Class II	1988-11-21
K883860	Advantage	Fischer Imaging Corp.	IZI	Class II	1988-11-21
K883831	Imager	Fischer Imaging Corp.	IZI	Class II	1988-11-21
K883818	Modified Reflux Reducer	Physician Engineered Products, Inc.	FMS	Class II	1988-11-21
K883793	Disposable Temperature Probes (Several Models)	Yellow Springs Instrument Co., Inc.	FLL	Class II	1988-11-21
K883668	Sunderland Nasal Tube	Exmoor Plastics Limited	BTQ	Class I	1988-11-21
K883383	Lifeguard Vent Mask	Breath of Life, Inc.	CBP	Class II	1988-11-21
K883186	Wright Gradient Pressure Support Stockings	Wright Linear Pump, Inc.	DWL	Class II	1988-11-21
K883133	Hanger, Intravenous/i.v. Bag Hanger or Holder	Ferguson Medical	FOX	Class I	1988-11-21
K884532	Triad-Ep II, Pushbutton, Cable Input	Cardiotronics, Inc.	DRO	Class II	1988-11-18
K884529	Microair Fluidized Air Bed	Gsi Development Co.	INX	Class II	1988-11-18
K884487	Lido Tm Active Back	Loredan Biomedical, Inc.	IKK	Class II	1988-11-18
K884392	Kbm Dental Mask	Kawamoto Bandage Material Co., Ltd.	FXX	Class II	1988-11-18
K884007	Cards(tm) Mono	Pacific Biotech, Inc.	KTN	Class II	1988-11-18
K883763	Acme Guidewires for Percutaneous Insertion of Cath	Acme-Monaco Corp.	KOD	Class II	1988-11-18
K883651	Millar Mikro-Tip Catheter Pressure Transducer	Millar LLC.	DQO	Class II	1988-11-18
K883577	Bard Infusor Pump	C.R. Bard Inc	FRN	Class II	1988-11-18
K880371	Bioglass Dental Endosseous Ridge Maintainer	American Biomaterials Corp.	LYC	Class II	1988-11-18
K884558	Iop Adjustable Stirrup	Mend Technologies, Inc.	BWN	Class I	1988-11-17
K884530	Triad-Ep II, Plate Input	Cardiotronics, Inc.	DRO	Class II	1988-11-17
K884514	Forceps, Towel, Backhaus-Tsk (Brand) Towel	Gatewood and Associates, Ltd.	GEN	Class I	1988-11-17
K884512	Beaver(r) Handle	BD Becton Dickinson Vacutainer Systems Preanalytic	GDZ	Class I	1988-11-17
K884457	Modular Collared Hjd Total Hip System	Richards Medical Co., Inc.	JDI	Class II	1988-11-17
K884448	Blademate	V.I.R. Engineering, Inc.	MMK	Class II	1988-11-17
K884387	Cushion Flex(tm)	Life Design Systems, Inc.	BSJ	Class I	1988-11-17
K884215	Minix 8340, 8341, 8342 Minix-St 8330, 8331	Medtronic, Inc.	DXY	Class III	1988-11-17
K884033	Biodynamics Model 200 Body Composition Analyzer	Biodynamics Corp.	DSB	Class II	1988-11-17
K883853	Eta	Sevrain-Tech, Inc.	LRA	Unclassified	1988-11-17
K883827	Masks, Various Types of Surgical Masks	Greene International Corp.	FXX	Class II	1988-11-17
K883755	Modified Spectrax Sx/sxt & Pasys/pasys St Models	Medtronic, Inc.	DXY	Class III	1988-11-17
K883643	Tdk ECG Electrode, Mel-10L	Tdk Corp.	DRX	Class II	1988-11-17
K883478	Diagnostic Audiometer, Model Midimate 602	Madsen Electronics (Canada), Ltd.	EWO	Class II	1988-11-17
K883211	Imz O-Ring Attachment	Interpore Intl.	DZE	Class II	1988-11-17
K882472	Logic 3 Electrocardiograph	Cel-Med Co., Inc.	DPS	Class II	1988-11-17
K882067	Marquette 1200 Defibrillator	Marquette Electronics, Inc.	MKJ	Class III	1988-11-17
K881876	Dynamic Cruciate Tester	Dyonics, Inc.	LYH	Class I	1988-11-17
K880738	Model 2331T Patient Programmer	Medtronic, Inc.	KRG	Class III	1988-11-17
K880404	Csi/qct	Columbia Scientific, Inc.	KGI	Class II	1988-11-17
K884526	Adult Resuscitator with Mask and Filter	Intertech/Ohio	BTM	Class II	1988-11-16
K884496	Ria/mat Fpa Test Kit	Altana, Inc.	DAN	Class II	1988-11-16
K884492	Micro Surgical Instrument System	Tava Surgical Instruments	HSZ	Class I	1988-11-16
K884276	Beckman Kappa Light Chain Reagent	Beckman Instruments, Inc.	DFH	Class II	1988-11-16
K884170	Analyst Theophylline Calibrator	The du Pont Co.	DLJ	Class II	1988-11-16
K884123	Amos Boy Lift Chair	Howard N. Amos Design & Mfg.	INO	Class II	1988-11-16
K884105	Amerlite Estradiol Assay, Lan.2080 (144 Test Kit)	Amersham Corp.	CHP	Class I	1988-11-16
K884068	Pulmanex Tm (Neo-Natal Size)	Life Design Systems, Inc.	BTM	Class II	1988-11-16
K884043	Grieshaber Micro Lite Light Pipe 19 & 20 Gauge	Grieshaber & Co.	HQE	Class II	1988-11-16
K883913	La Masseuse	Sobel Shipping Co., Inc.	IRO	Class I	1988-11-16
K883854	Dexsol	Northern Scientific, Inc.	LYX	Unclassified	1988-11-16
K883724	Gemini Femoral Hip Prosthesis	Depuy, Inc.	JDI	Class II	1988-11-16