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 2510 of 3531

510(k) clearances, page 2510 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903897	Triglycerides Reagent Gpo 5 X Conc.	Trace Scientific, Ltd.	CDT	Class I	1990-10-01
K903822	Model 4500-Sms-42; Shoulder Coil	Medical Advances, Inc.	LNH	Class II	1990-10-01
K903456	Premier-C. Difficile Toxin a	Meridian Diagnostics, Inc.	LLH	Class I	1990-10-01
K903446	Comfit Surgeon's Gloves	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1990-10-01
K903403	CT-Compatible Fletcher System Applicator	University of Michigan	IWJ	Class I	1990-10-01
K903375	Hicor	Siemens Gammasonics, Inc.	IZI	Class II	1990-10-01
K903323	Resectoscope Loops	Olympus Corp.	KNS	Class II	1990-10-01
K903096	Rack-It (R)	Vengo Industries, Inc.	FLE	Class II	1990-10-01
K903015	Synermed Cholesterol Reagent Kit	Synermed, Inc.	CHH	Class I	1990-10-01
K902808	Driptrol	Trans-Pacific Healthcare-USA	FLN	Class II	1990-10-01
K902641	Rpi Enteral Feeding Bag 1000Ml and 500Ml	Ridge Products, Inc.	KNT	Class II	1990-10-01
K902320	Bauer Flexi-Temno Biopsy Needle	Proact, Ltd.	FCG	Class II	1990-10-01
K902084	Ohmeda 7800 Anesthesia Ventilator Software Update	GE Healthcare	CBK	Class II	1990-10-01
K901290	Electro-Goniometer Diagnostic Device	Chattanooga Group, Inc.	LBB	Class II	1990-10-01
K893582	N-a-G Test Kit	Ppr Diagnostics, Ltd.	CGX	Class II	1990-10-01
K903724	Beamer 1,2,4,6, and 8	Beacon Laboratories, Inc.	GEI	Class II	1990-09-28
K902953	Softouch Guiding Catheter	Mallinckrodt Medical	DQO	Class II	1990-09-28
K902715	Surgical Towel	Aztec Medical, Inc.	KKX	Class II	1990-09-28
K902032	O. B. Pack IV	Customed, Inc	HFC	Class II	1990-09-28
K901978	Multi-Drug Infusion System	Halyard Health	FRN	Class II	1990-09-28
K901521	Osteotomes of Various Types	Mumtaz I. Malik	LXH	Class I	1990-09-28
K901511	Chisel, Bone, Surgical	Mumtaz I. Malik	LXH	Class I	1990-09-28
K901420	Volkman Bone Currette 5, 5-3/4, 6-3/4, 8	Mumtaz I. Malik	LXH	Class I	1990-09-28
K901289	Rongeur, Orthopedic Surgical Instruments	Mumtaz I. Malik	LXH	Class I	1990-09-28
K901162	Sterimatic(tm) Safety Needle	Sterimatic Worldwide, Ltd.	FMI	Class II	1990-09-28
K897086	Parker Ambulatory Medication Infusion Pump 2004	Parker Hannifin Corp.	FRN	Class II	1990-09-28
K896758	Gambro Bicarbonate Monitor Bcm 10-3	Gambro, Inc.	FKP	Class II	1990-09-28
K904188	Ciba Corning Model 238 Ph/ Blood Gas Analyzer	Ciba Corning Diagnostics Corp.	CHL	Class II	1990-09-27
K904116	Iron 5 X Conc Reagent	Trace Scientific, Ltd.	JMO	Class I	1990-09-27
K904102	Reflotron Creatine Kinase Test Tabs	Boehringer Mannheim Corp.	CGS	Class II	1990-09-27
K904098	Cedia Total T3 Assay	Microgenics Corporation	CDP	Class II	1990-09-27
K904030	Synermed Alkaline Phosphatase Reagent Kit	Synermed, Inc.	CJE	Class II	1990-09-27
K903973	Gardosi Birthing Cushion	Graphic Controls Corp.	KNC	Class II	1990-09-27
K903934	Gen-Probe Luminometer-Leader 50	Hologic, Inc.	JJQ	Class I	1990-09-27
K903913	Paramax Urine/csf Calibrator Level I and II	Baxter Healthcare Corporation	JIX	Class II	1990-09-27
K903888	Hi Chem Protein/lipids Linearity	Hichem Diagnostics	JIX	Class II	1990-09-27
K903825	Drug of Abuse Analysis System	Technicon Instruments Corp.	DIS	Class II	1990-09-27
K903824	Drug of Abuse Analysis System Free Radical Assay	Technicon Instruments Corp.	DKZ	Class II	1990-09-27
K903727	Synermed Uric Acid Reagent Kit	Synermed, Inc.	KNK	Class I	1990-09-27
K903606	Guidewire Torque Device and Guidewire Introducer	North American Instrument Corp.	LIT	Class II	1990-09-27
K903558	Laser Cane	Nurion Industries	HPG	Class I	1990-09-27
K903527	Magnetic Resonance Diagnostic Device-or 41 Magnet	Siemens Medical Solutions USA, Inc.	LNH	Class II	1990-09-27
K903357	Syva(r) Ets(r) Plus System	Syva Co.	JJF	Class I	1990-09-27
K903305	Technicon Chem I System Carbon Dioxide Method	Technicon Instruments Corp.	KHS	Class II	1990-09-27
K903231	Coulochem II	Esa, Inc.	LEQ	Class I	1990-09-27
K903158	Siterite Needle Guide	Dymax Corp	DQY	Class II	1990-09-27
K903071	Kodak Ektachem Solution 7%Bsa Bovine Serum Albumin	Eastman Kodak Company	JJE	Class I	1990-09-27
K902935	Roche Cobas Ready Hdl Cholesterol Reagent	Roche Diagnostic Systems, Inc.	JHM	Class I	1990-09-27
K902875	Intelect 750 Mp	Chattanooga Group, Inc.	IMG	Class II	1990-09-27
K902873	Nonabsorbable Dacron Surgical Suture*	United States Surgical, A Division of Tyco Healthc	GAS	Class II	1990-09-27