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 2698 of 3530

510(k) clearances, page 2698 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883065	Alloprep System	Osteotech Inc	KIT	Class I	1988-10-13
K882934	Casf Cancellous Bone Screw, Bt650	Terray Manufacturing, Inc.	HWC	Class II	1988-10-13
K882758	Centrifugal Pump System Lx/dx Version	3M Health Care, Sarns	KFM	Class II	1988-10-13
K882695	Rubber Band, Sterile	Bioseal	ECI	Class I	1988-10-13
K882560	Ciba Corning Magic Lite Intact Pth Immunoassay	Ciba Corning Diagnostics Corp.	CEW	Class II	1988-10-13
K881862	Thermo-Body-Wrap System	Thermo Body Wrap Systems, Inc.	IRT	Class II	1988-10-13
K881810	Medtronic Model 4951P	Medtronic, Inc.	DTB	Class III	1988-10-13
K880924	Inter Tron 4000	Diversified Chiropractic Systems	LIH	Class II	1988-10-13
K883999	Quidel Group a Strep Test	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1988-10-12
K883996	X-Act Ldc/ind	Pro-Lab, Inc.	JSE	Class I	1988-10-12
K883995	X-Act Urea/tda	Pro-Lab, Inc.	JSE	Class I	1988-10-12
K883992	Kvm Prepack Hematology Reagent Set	Kvm Technologies, Inc.	GKK	Class II	1988-10-12
K883991	Kvm Hemoglobin Lysing Reagent	Kvm Technologies, Inc.	GGK	Class I	1988-10-12
K883990	Kvm Isotonic Diluent	Kvm Technologies, Inc.	GIF	Class I	1988-10-12
K883989	Kvm Isotonic Flush Solution	Kvm Technologies, Inc.	GIF	Class I	1988-10-12
K883910	Acufex Interference Screw and Screwdriver	Acufex Microsurgical, Inc.	HWC	Class II	1988-10-12
K883800	Sceptor Gram-Negative Breakpoint/id Panel	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-10-12
K883798	Sceptor Gram-Positive Breakpoint/id Panel	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-10-12
K883792	Total Iron for Continuous Flow Instruments	Catachem, Inc.	JIY	Class I	1988-10-12
K883758	Albabond 60	Degussa Dental, Inc.	EJT	Class II	1988-10-12
K883736	Sterile Surgeons Gloves	Medical Manufacturers Marketing Co.	KGO	Class I	1988-10-12
K883610	Lake Foley Catheterization Tray	Lake Medical Products, Inc.	FCN	Class II	1988-10-12
K883465	Ortho-Seal	Bisco, Inc.	DYH	Class II	1988-10-12
K883437	Dental Chair	E.F. Brewer Co.	KLC	Class I	1988-10-12
K883416	Mouthpiece Breathing (Performance Mouthguard)	Scott All-Sports, Inc.	JXL	Class II	1988-10-12
K883307	Cardioflow 100 Hemoconcentrator/preparation Kit	Hospal Medical Corp.	KDI	Class II	1988-10-12
K883242	Extravakit for Dimethylsulfoxide (Dmso)	Cancer Technologies, Inc.	FMF	Class II	1988-10-12
K883234	Tonomitor (Tm) + Sump	Tonometrics, Inc.	FFT	Class I	1988-10-12
K883183	Tracer Bone Mill	De Medica Mfg., Inc.	LYS	Class I	1988-10-12
K882953	Hydramed by Lechler	Lechler, Inc.	CAF	Class II	1988-10-12
K882895	Modified Beta Quik Stat Eia Kit	Pacific Biotech, Inc.	DHA	Class II	1988-10-12
K882571	Kolynos Dental Floss	Whitehall Laboratories, Inc.	JES	Class I	1988-10-12
K882551	Ambulatory Ph Data Recorder System, Aph-2000	Intl. Biomedics, Inc.	KLA	Class II	1988-10-12
K882478	100-01778-52 Ultrasound System	Diasonics, Inc.	IYO	Class II	1988-10-12
K881481	Digitron Stenosis Protocol	Siemens Gammasonics, Inc.	LLZ	Class II	1988-10-12
K881259	Mak-6 Monoclonal Anti-Cytokeratin Cocktail	Triton Biosciences, Inc.	LYE	Class II	1988-10-12
K881008	Maxerect	Kenneth Chapman	LKY	Class II	1988-10-12
K874923	Pca Modular Total Knee-Universal Tibial Baseplate	Howmedica Corp.	JWH	Class II	1988-10-12
K884132	Tecnol Bucks Traction W/heel Protector	Technol, Inc.	KQZ	Class I	1988-10-11
K884022	Emit D.a.u. Monoclonal Amphetamine/methamphetamine	Syva Co.	DKZ	Class II	1988-10-11
K883920	Emit D.a.u. Low Calibrator a & Medium Cali. a	Syva Co.	DLJ	Class II	1988-10-11
K883731	Tdx Cannabinoids-Gs	Abbott Medical	LDJ	Class II	1988-10-11
K883460	Focus Total Hip System	Depuy, Inc.	JDI	Class II	1988-10-11
K883264	Sl Series Accelerators Sl15, Sl18, Sl20 & Sl25	Philips North America LLC	IYE	Class II	1988-10-11
K882736	Amerlite Reproductive Endocrinology Control Sera	Amersham Corp.	JJY	Class I	1988-10-11
K882378	P-7 Computed Tomography System	Philips North America LLC	JAK	Class II	1988-10-11
K880440	Protect-Aids Autopsy Underglove	Medical Armor Corp.	LYU	Class I	1988-10-11
K880439	Protect-Aids Underglove	Medical Armor Corp.	LYU	Class I	1988-10-11
K884076	Surebreath Dome	Ipax, Inc.	GAD	Class I	1988-10-07
K884072	15 Millimeter Male and Female Adapters	Eastmed Enterprises, Inc.	CAI	Class I	1988-10-07