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 2261 of 3531

510(k) clearances, page 2261 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933514	Bacticard Strep	Remel Inc	JTO	Class I	1993-10-28
K933437	Dade Anemia/hemochromatosis Contols,level 1,Level 2,And Level 3	Baxter Diagnostics, Inc.	JJY	Class I	1993-10-28
K933397	Genzyme a-Amylase Test Reagent	Genzyme Corporation	JFJ	Class II	1993-10-28
K933354	Hobbs Medical Cleaning Brush	Hobbs Medical, Inc.	FEB	Class II	1993-10-28
K933072	Pci 2500	Pci	IPF	Class II	1993-10-28
K933026	Synermed Direct Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1993-10-28
K932912	Stratus Free Thyroxine (Free T4) Fluorometric	Baxter Diagnostics, Inc.	CEC	Class II	1993-10-28
K932660	Ld-1 Isoenzyme Control (Human) Level 1 & 2	More Diagnostics Inc.	JJX	Class I	1993-10-28
K932442	Cardio Rep Recombinant Ck Abnormal Control	Helena Laboratories, Corp.	JJT	Class I	1993-10-28
K931559	Dma Amylase Procedure	Data Medical Associates, Inc.	CIW	Class II	1993-10-28
K926275	Philips MRI Breast Coil	Philips North America LLC	LNH	Class II	1993-10-28
K925993	Duoderm Hydroactive Dressing	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1993-10-28
K925991	Duoderm Cgf Control Gel Formula Dressing & Border	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1993-10-28
K925990	Duoderm Extra Thin Cgf Dressing	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1993-10-28
K934753	Star Breathing Circuits	Infrasonics Corp.	BZO	Class I	1993-10-27
K934467	Beckman Cx Ammonia/alcohol Control	Beckman-Diagnostic Systems Group	DKC	Class I	1993-10-27
K934172	Acro-Poly, Inc. Handpiece/anglehead Accessories for Surgical Instuments	Acro-Poly, Inc.	GEY	Class I	1993-10-27
K933707	Capnodig	Spegas Industries, Ltd.	CCK	Class II	1993-10-27
K933515	Booty Endoscope Warmer	T-Med, Inc.	GCI	Class II	1993-10-27
K933444	Stago Factor XI-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1993-10-27
K933441	Stago Factor X-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1993-10-27
K933440	Stago Factor VII-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1993-10-27
K933438	Stago Factor XII-Deficient Plasma	American Bioproducts Co.	GJT	Class II	1993-10-27
K933319	Birtcher Gs-9480 Integrated 3-Chip Camera/xenon Light Source Visualization System	Birtcher Medical Systems, Inc.	GCY	Class I	1993-10-27
K933204	Bard PTFE Vascular Graft	C.R. Bard Inc	DSY	Class II	1993-10-27
K932698	Isi(r) Hook Sutures Scissors	Innovative Surgical, Inc.	GCJ	Class II	1993-10-27
K932498	Mobile Care IV Stand	Mobile Care, Inc.	FOX	Class I	1993-10-27
K932185	Surgical Suction Tip	Tlc Medservices, Inc.	JOL	Class II	1993-10-27
K930785	The De Soutter M182 Drill	De Soutter Medical Ltd.	HSZ	Class I	1993-10-27
K930784	The De Soutter M193 Reamer	De Soutter Medical Ltd.	HSZ	Class I	1993-10-27
K930302	Birtcher Sure Clean Instrument System	Birtcher Medical Systems, Inc.	GCI	Class II	1993-10-27
K925328	Anspach Bone Rivet, Anspach Suture Anchor	Anspach Mfg., Inc.	HWC	Class II	1993-10-27
K924698	Axiom Total Knee System, Modular Tibial Tray	Orthomet, Inc.	JWH	Class II	1993-10-27
K924517	Avitene Dispenser Syringe	Nusurg, Inc.	KYZ	Class I	1993-10-27
K923841	Bone Screws	Instrument Makar, Inc.	HWC	Class II	1993-10-27
K923290	Computer - Computers and Software, Medical Use	A Mixed Bag Corp.	FRN	Class II	1993-10-27
K921114	Exactech Mcs Porous Coated Total Hip Acetabular	Exactech, Inc.	LPH	Class II	1993-10-27
K921113	Exatech Mcs Porous Coated Total Hip Femoral Stem	Exactech, Inc.	LPH	Class II	1993-10-27
K934117	Stabiltube	Garrett Medical Products	BTR	Class II	1993-10-25
K933006	Avi Infusion Pumps, Additional Intended Use	3M Company	FRN	Class II	1993-10-25
K933005	Avi Model 600 Syringe Pump	3M Company	FRN	Class II	1993-10-25
K932900	Aircast Venaflow System	Aircast, Inc.	JOW	Class II	1993-10-25
K932344	Magnetic Resonance Diagnostic Device Accessories	Siemens Medical Solutions USA, Inc.	LNH	Class II	1993-10-25
K932188	Safeset Reservoir	Abbott Medical	KRA	Class II	1993-10-25
K932170	Flynnr Genesis II A/c, A/o and Idlh	O-Two Systems Intl., Inc.	BTL	Class II	1993-10-25
K932011	Pathromtin	Behring Diagnostics, Inc.	GFO	Class II	1993-10-25
K932006	1500 Series Regulator	Precision Medical, Inc.	CAN	Class I	1993-10-25
K931633	Powder-Free Latex Patient Examination Gloves	Tomarc (M) Sdn Bhd	LYY	Class I	1993-10-25
K931542	Newport Compass Exhaled Tidal Volume Monitor	Newport Medical Instruments, Inc.	BZK	Class II	1993-10-25
K926252	Cathscanner II Intravascular Ultrasonic Imaging Sy	Endosonics Corp.	IYO	Class II	1993-10-25