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 2348 of 3531

510(k) clearances, page 2348 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920117	Halo Esprit	Itm Corp.	JEC	Class II	1992-10-06
K913593	Ohmeda Tec 6 Continuous Flow Vaporizer	GE Healthcare	CAD	Class II	1992-10-06
K924450	Mediphonix Custom Full Shell Custom Canal	Mediphonix, Inc.	ESD	Class I	1992-10-05
K923864	Battery Pack	Portable Power Systems, Inc.	LDD	Class II	1992-10-05
K923859	Premier Blastomyces	Meridian Diagnostics, Inc.	MJL	Class II	1992-10-05
K923771	Pulse RF Test	Pulse Scientific, Inc.	DHR	Class II	1992-10-05
K923700	Indoxyl Acetate Disk	Remel Inc	JTO	Class I	1992-10-05
K923665	Reusable Dual Disc Bar Recording Electrodes	Chalgren Enterprises, Inc.	JXE	Class II	1992-10-05
K923469	Oralsafe	Oralsafe, Inc.	EFB	Class I	1992-10-05
K923454	Shimadzu Image Amplifier Ia-9Ls Series	Shimadzu Medical Systems	JAA	Class II	1992-10-05
K923453	Shimadzu Image Amplifier Ia-9Lm Series	Shimadzu Medical Systems	JAA	Class II	1992-10-05
K923292	Itc Hearing Aid Club Model Lm50	Club Hearing Instruments A/S	ESD	Class I	1992-10-05
K923255	Q-Sd	Quantitative Medicine, Inc.	GZJ	Class II	1992-10-05
K923210	System 3000 Xenon Videolap Light	Cabot Medical Corp.	GCT	Class II	1992-10-05
K922940	Clincal Hand Master System Model # Exh9000-002	Exos, Inc.	LBB	Class II	1992-10-05
K922921	King Diagnostics Chloride Reagent	King Diagnostics, Inc.	CHJ	Class II	1992-10-05
K922759	Hsv-2 Igm Elisa Test--Modification	Gull Laboratories, Inc.	LGC	Class II	1992-10-05
K922758	Hsv-1 Igm Elisa Test -- Modification	Gull Laboratories, Inc.	LGC	Class II	1992-10-05
K922726	Tech Simple Infectious Mononucleosis Serum Control	Simplicity Diagnostics, Inc.	KTN	Class II	1992-10-05
K922725	Tech Simple Rheumatoid Factor Serum Control	Simplicity Diagnostics, Inc.	DHR	Class II	1992-10-05
K922722	Tech Dimple C-Reactive Protein Serum Control	Simplicity Diagnostics, Inc.	DCK	Class II	1992-10-05
K922715	Immuchem Prl-Mw Elisa	Icn Biomedicals, Inc.	CFT	Class I	1992-10-05
K922376	Icn Biomedicals Immuchem(tm) Fsh-Mw Elisa Kit	Icn Biomedicals, Inc.	CGJ	Class I	1992-10-05
K921886	Needle Technologies Seed Implant Needle	Needle Technologies, Inc.	IWJ	Class I	1992-10-05
K921798	Propper Super Seracult(r)	Propper Mfg Co Inc	KHE	Class II	1992-10-05
K921490	Dressing Change Tray Decubitus Ulcer/sterile-Disp	Trinity Laboratories, Inc.	FRG	Class II	1992-10-05
K921426	Ultra Pci	Advanced Medical Products, Inc.	IYO	Class II	1992-10-05
K921304	Ddv Ligator	North American Medical Corporation	KOA	Class I	1992-10-05
K921129	Mrx-700	Mrx-Ray Tube Corp.	ITY	Class I	1992-10-05
K921116	Px-100 Portable X-Ray Generator	Acoma Medical Imaging, Inc.	IZL	Class II	1992-10-05
K920840	Otovent	Abigo Medical AB	MJV	Unclassified	1992-10-05
K920203	Tecnol Infection Control Mask	Tecnol Medical Products, Inc.	FXX	Class II	1992-10-05
K914193	A&e Medical Corp Dispos Suct Coag W/non Stick Coat	Alto Development Corp	GEI	Class II	1992-10-05
K914148	Prime Cadi-120	Prime Medical Products, Inc.	MEB	Class II	1992-10-05
K912791	Salmonella O Grouping Antisera Set	S.M.I. Medical, Inc.	GRM	Class II	1992-10-05
K912419	Cordguard Blood Collection Device	O.B. Tech., Inc.	HFW	Class II	1992-10-05
K923610	Olympus Chloride Reagent	Olympus Corp.	CHJ	Class II	1992-10-02
K923609	Olympus Total Bilirubin Reagent	Olympus Corp.	CIG	Class II	1992-10-02
K923607	Radifocus Guide Wire M	Terumo Medical Corp.	KOD	Class II	1992-10-02
K923346	Olympus Amylase Reagent	Olympus Corp.	JFJ	Class II	1992-10-02
K920937	Computerized Pupil	Trek Medical Products, Inc.	HLG	Class I	1992-10-02
K923376	Visual Hcg Pregnancy Test	Tech-Co, Inc.	JHI	Class II	1992-10-01
K922509	Laparoscopic Electrosurg Device W/irriga & Aspira	Everest Medical Corp.	GEI	Class II	1992-10-01
K922255	Latex Examination Gloves	Balak Rubber (Malaysia) Sdn. Bhd.	LYY	Class I	1992-10-01
K921848	Bfw Wehmerlite IV-a Fiber Optic Surg. Headlight	Alm Surgical Equipment, Inc.	FSQ	Class II	1992-10-01
K921747	Micro Trak Xl System	Syva Co.	LJC	Class I	1992-10-01
K921708	Cytocare Laser Catheter for Urology	Cytocare, Inc.	GEX	Class II	1992-10-01
K921339	Hand-E-Breath	Jerry Mccarty	CAF	Class II	1992-10-01
K921049	Surgical Drape	Amsco Sterile Recoveries, Inc.	KKX	Class II	1992-10-01
K921014	Model M2350a and M2360a Wavevue Central Monitor	Hewlett-Packard Co.	MHX	Class II	1992-10-01