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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3101 of 3528

510(k) clearances, page 3101 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834307	Ultrasound Scanner Xl	Interad Systems, Inc.	IYO	Class II	1984-02-21
K834300	Hybritech Data Station	Hybritech, Inc.	JQP	Class I	1984-02-21
K834100	Pre-Calibrated Pipettes	Vitex	JRC	Class I	1984-02-21
K834072	Instrument, Dental	Venture Technology, Inc.	EMS	Class I	1984-02-21
K834055	Vanadium Excavators Sizes 0-6	Henry Schein, Inc.	EKC	Class I	1984-02-21
K833939	Nitroglycerin i.v. Administration Set	Critikon Company, LLC	FPA	Class II	1984-02-21
K833883	Digital Audiometer/hearing Aid 3100	Frye Electronics, Inc.	EWO	Class II	1984-02-21
K833810	Curay-Match Paint-on Composite Restor	Scientific Pharmaceuticals, Inc.	EBF	Class II	1984-02-21
K833784	Disposable I/a Handpiece	CooperVision, Inc.	HQC	Class II	1984-02-21
K833454	Biorem 3000 & 4000	Biorem	LIL	Unclassified	1984-02-21
K833401	Omyl -Arde- Spectacle Frame	I.J. Langleb, Ltd.	HQZ	Class I	1984-02-21
K832647	Articulating Paper	Ardent Intl., Inc.	EFH	Class I	1984-02-21
K840478	Emco Wheelchair	Emco Medical Supply	IOR	Class I	1984-02-17
K840467	Neuromuscular Stimulator 3105	Medtronic, Inc.	IPF	Class II	1984-02-17
K840459	Improved Mouthpiece	Kinetix	BYP	Class I	1984-02-17
K840452	Premium Dabm Dispos. Anes. Breath Mask	Ohio Medical Products	BSJ	Class I	1984-02-17
K840418	Inspiratory/expiratory Muscle Exercis	Inspiron Corp.	BWF	Class II	1984-02-17
K840361	Oxygen Analyzer 200	Salter Labs	CCL	Class II	1984-02-17
K840357	Ssa Hip Prosthesis	Dow Corning Corp. Healthcare Industries Materials	JDI	Class II	1984-02-17
K840336	Radiopaque 7 Frx 12-Polyurethane Multi	Arrow Intl., Inc.	DQY	Class II	1984-02-17
K840294	Group a Selective Agar W/5% Sheep Blood	BD Becton Dickinson Vacutainer Systems Preanalytic	JSI	Class I	1984-02-17
K840256	Cardioplegia Heat Exchanger Holder	American Bentley	DTR	Class II	1984-02-17
K840190	Macconkey Agar W/tween 80 & Ampicil	Remel Co.	JSI	Class I	1984-02-17
K840108	Neuromuscular Transmission Monitor	Datex Division Instrumentarium Corp.	KOI	Class II	1984-02-17
K840054	Papanicolaou Stain Sys Ht40	Sigma Chemical Co.	HZJ	Class I	1984-02-17
K834500	Solution Transfer Set	Berlex Laboratories, Inc.	LHI	Class II	1984-02-17
K834475	Respirodyne Pulmonary Function Test	Chesebrough-Pond'S U.S.A. Co.	BZG	Class II	1984-02-17
K834467	Specimen Trap	Microvasive	BYZ	Class II	1984-02-17
K834285	Kc 100 M	Elscint, Inc.	IYO	Class II	1984-02-17
K834277	Mod 427	Hoffrel Instruments, Inc.	IYO	Class II	1984-02-17
K834276	Mod 456	Hoffrel Instruments, Inc.	IYO	Class II	1984-02-17
K834127	Instrument Tip Protection Covers	Devon Industries, Inc.	LXZ	Class I	1984-02-17
K834047	Pmt-Halo/orthopedic Jacket System	Progress Mankind Technology	HAX	Class II	1984-02-17
K833972	Quick-Count Hematology Reagent Kit	Seragen Diagnostics, Inc.	GIF	Class I	1984-02-17
K833680	Sigma 20 Electronic Sector Scanner	Kontron Instruments, Inc.	IYO	Class II	1984-02-17
K833626	Floret Foam Prep Sponge	Ritmed, Inc.	GDY	Class I	1984-02-17
K832951	Memory Loop Transmitter #121	Biometric Products, Inc.	DXH	Class II	1984-02-17
K840641	Vessel Dilator	Aries Medical, Inc.			1984-02-14
K834615	Triple Lumen Infusioncatheters-	Medical Components, Inc.	JCY	Class I	1984-02-14
K840076	Gn Broth Tube	Otisville Biotech, Inc.	JSJ	Class I	1984-02-13
K840074	Kv Blood Agar Plate	Otisville Biotech, Inc.	JSJ	Class I	1984-02-13
K840067	Thayer-Martin Agar Plate	Otisville Biotech, Inc.	JTY	Class II	1984-02-13
K840066	Chocolate Agar Muellerh-Hinton Base	Otisville Biotech, Inc.	JTZ	Class II	1984-02-13
K840065	Chocolate Agar Gc Base Plate	Otisville Biotech, Inc.	JTY	Class II	1984-02-13
K840045	Cardioplegia Heat Exchanger He-100	American Bentley	DTR	Class II	1984-02-13
K840005	Nabi RF-Q.s. Test	Intl. Diagnostic, Inc.	DHR	Class II	1984-02-13
K840002	Arterial Cannula Curved Beveled Tip	Dlp, Inc.	DWF	Class II	1984-02-13
K840001	Arterial Cannula Straight Beveled Tip	Dlp, Inc.	DWF	Class II	1984-02-13
K834581	Differentiation Disks Hippurate	Difco Laboratories, Inc.	JTO	Class I	1984-02-13
K834562	Enternal Feeding Tube	Sheridan Catheter Corp.	KNT	Class II	1984-02-13