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 2026-11-02, 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 2396 of 3531

510(k) clearances, page 2396 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915056	Fingguard	Allied Signal, Inc.	LYU	Class I	1992-02-03
K914968	Disposable Trocar Sleeve with Dilating Obturator	Ethicon, Inc	HET	Class II	1992-02-03
K914956	Keeler Konan Specular Microscope Sp5500	Keeler Instruments, Inc.	HRM	Class I	1992-02-03
K914843	Kinamed Ath-Ha & Ath-Ha Long Total Hip	Kinamed Inc	MEH	Class II	1992-02-03
K914741	Amer Profile Miller Laryngoscope Blades, Modified	Eastmed Enterprises, Inc.	CCW	Class I	1992-02-03
K914612	Meron Dental Cement	Voco GmbH	EMA	Class II	1992-02-03
K914147	Allevlyn Wound Dressing, Modification	Smith & Nephew United, Inc.	KMF	Class I	1992-02-03
K913768	Pec Implant	Applied Biomaterial Technologies	MIC	Class II	1992-02-03
K913732	Mammographic X-Ray System	Lorad Medical Systems, Inc.	IZH	Class II	1992-02-03
K913200	Gti Clasp Cover	Gti, Inc.	EBF	Class II	1992-02-03
K913163	Non Rebreathing Valve	Specialty Packaging Producs, Inc.	CBP	Class II	1992-02-03
K912996	Modif Top Drive Board Cxt-90 90/90 Diag Tilt Table	Continental X-Ray Corp.	IXR	Class II	1992-02-03
K912993	Wilde Denture Resins	Wilde-USA, Inc.	EBI	Class II	1992-02-03
K912901	Trojan (Tm-Tbd) Condom	Carter Products	HIS	Class II	1992-02-03
K912835	Mini-Pack 911 Series	Pace Tech, Inc.	MHX	Class II	1992-02-03
K910874	Thoracic Anterior Spinal Fixation Plate	Terray Manufacturing, Inc.	KWQ	Class II	1992-02-03
K915667	Model H170 Pediatric Chest X-Ray Unit	H.L. Lyons Co.	IXY	Class I	1992-01-31
K915635	Curity Vented Dressing System	Kendall Healthcare Products Co. Div.Of Tyco Health	MGP	Unclassified	1992-01-31
K915598	Special Purpose Coils for Gyrex V	Elscint, Inc.	LNH	Class II	1992-01-31
K915489	Auto Suture Absorable Subcuticular Closure Staple	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1992-01-31
K915377	Sr-Ivocap Plus	Ivoclar North America, Inc.	EBI	Class II	1992-01-31
K915355	Ads-Gel and Insulating-Gel	Kulzer GmbH	EBF	Class II	1992-01-31
K915299	Cogan Corp Kits of Dental Hand Instruments	Cogan Corp.	EGG	Class I	1992-01-31
K915240	Natural-Knee Tibial and Femoral Spacers	Intermedics Orthopedics	HSX	Class II	1992-01-31
K915203	D-Dimer Wellcotest (Ha10)	Wellcome Diagnostics	DAP	Class II	1992-01-31
K915184	Howmedica Alumina Femoral Head	Pfizer Hospital Products Group, Inc.	LZO	Class II	1992-01-31
K915111	Pontor Mpf,v-Gnathos Pf,24k Casting Gold	Metalor Dental USA Corp.	EJT	Class II	1992-01-31
K915081	Mitek Snap Pak(tm), Modification	Mitek Surgical Products, Inc.	GAS	Class II	1992-01-31
K915061	Proact Cla-1500 System	Clinical Systems, Inc.	FNM	Class II	1992-01-31
K915002	Sterile Gauze Pk Strips Sat W/carr Gel Wound Dress	Carrington Laboratories, Inc.	MGQ	Unclassified	1992-01-31
K915001	Carrington Wound Dressing 4X4(tm)	Carrington Laboratories, Inc.	MGQ	Unclassified	1992-01-31
K914942	Perry(r) Cut-Resistant Gloves	Smith & Nephew Perry	LYY	Class I	1992-01-31
K914935	Heart Pack II	Westmark Hospital Supplies	LRO	Class II	1992-01-31
K914933	Heart Pack III	Westmark Hospital Supplies	KOD	Class II	1992-01-31
K914932	Suture Removal Kit	Westmark Hospital Supplies	FRG	Class II	1992-01-31
K914929	Laceration Tray	Westmark Hospital Supplies	KKX	Class II	1992-01-31
K914927	Dressing Change Kit	Westmark Hospital Supplies	LYY	Class I	1992-01-31
K914840	Dermaproof	Pharmalett Medical Care, Holland B.V.	FRO	Unclassified	1992-01-31
K914701	Sil-K	Degania Silicone, Inc.	MDA	Class I	1992-01-31
K914595	Pulse Rate Monitor	Fitness Quest, Inc.	DPZ	Class II	1992-01-31
K914232	Asra, Screening Audiometer	Mercury Electronics (Scot), Ltd.	EWO	Class II	1992-01-31
K913622	Hemoplus	Sarstedt ApS	KHE	Class II	1992-01-31
K913239	Goldlens(tm)	Doran Instruments, Inc.	HLZ	Class II	1992-01-31
K913067	Dgh-4000 a-Scan/pachymeter	DGH Technology, Inc.	IYO	Class II	1992-01-31
K912576	Instrument Wipe and Corneal Shield	Katena Products, Inc.	HOY	Class I	1992-01-31
K905023	Amset Locking Plate System	Advanced Med/Surg, Inc.	KWQ	Class II	1992-01-31
K920093	Audiotone Model a-96	Miracle-Ear, Inc.	ESD	Class I	1992-01-30
K915806	Milenia Data Reduction	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1992-01-30
K915797	Calibrator	Alko Diagnostic Corp.	JIX	Class II	1992-01-30
K915769	Modified Memorytrace Er Model 4221 ECG Monitor	Medtronic, Inc.	DXH	Class II	1992-01-30