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 2326 of 3531

510(k) clearances, page 2326 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924222	Mid Labs, Inc. Vit Mate	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1993-01-27
K923798	Surgical Gown Pack	Central Georgia Ancillary Health Systems	KKX	Class II	1993-01-27
K923688	N-Pac	National Healthcare Linen Service	KKX	Class II	1993-01-27
K923660	Medisonic Oxygen Flow Controller	Medisonic U.S.A., Inc.	NFB	Class II	1993-01-27
K922968	Vinyl Exam Gloves	Normandin Pacific Holdings Corp.	LYZ	Class I	1993-01-27
K922811	Roche Cobas Futura Glucose	Roche Diagnostic Systems, Inc.	CFR	Class II	1993-01-27
K922786	Therm O Drug Model Ht-747	C.F. Electronics, Inc.	LGZ	Class II	1993-01-27
K922738	Vti Oxygen Analyzer	Vascular Technology Incorporated	CCL	Class II	1993-01-27
K922464	Sunglasses	Wing Shing Optical Manufacturers, Ltd.	HQY	Class I	1993-01-27
K921513	Spirolite Model Msc-201 Spirometer	Medical Systems Corp.	BZG	Class II	1993-01-27
K921288	Curity Calibrated Tuohy Type Epidural Needle	Kendall Healthcare Products Co. Div.Of Tyco Health	BSP	Class II	1993-01-27
K920305	Pharmaseal Clear Hub Spinal Needle	Baxter Healthcare Corporation	BSP	Class II	1993-01-27
K920162	Tecnol Fluidshield W/splashguard Vis Infec Cont Mk	Tecnol Medical Products, Inc.	FXX	Class II	1993-01-27
K915817	Tecnol Fluidshield Infection Control Mask	Tecnol Medical Products, Inc.	FXX	Class II	1993-01-27
K915780	Rack and Syringes	Normeca Corp.	FMF	Class II	1993-01-27
K915591	Sterile Gauze Pads	Eagle Medical, Inc.	NAB	Class I	1993-01-27
K915306	The Kaufmann Lift-and-Turn Mattress	Kaufmann Sjukvardsartiklar	FNM	Class II	1993-01-27
K926308	Lifesign Hcg - One Step Home Pregnancy Test	Princeton Biomedix	LCX	Class II	1993-01-26
K926256	Bbl Ninhydrin Reagent Droppers	Becton Dickinson Microbiology Systems	JTO	Class I	1993-01-26
K926255	Bbl Nitrate a, B Reagent Droppers	Becton Dickinson Microbiology Systems	JTO	Class I	1993-01-26
K926254	Bbl Pyr Reagent Droppers	Becton Dickinson Microbiology Systems	JTO	Class I	1993-01-26
K926095	Refractrol-Sp	Medical Specialties Inc.	JJX	Class I	1993-01-26
K925826	Encore Thyroglobulin Ige, Iga and Igm Eia	Trinity Biotech USA	JZO	Class II	1993-01-26
K925547	Maxsoftware	Siemens Healthcare Diagnostics Inc.	JQW	Class I	1993-01-26
K925337	Olympus Gamma Glutamyl Transferase Reagent	Olympus Corp.	JQB	Class I	1993-01-26
K925231	Meridian Medical Systems Mapleson D Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-01-26
K925217	Meridian Medical Systems Breathing Filter	Merit Medical Systems, Inc.	CAH	Class II	1993-01-26
K925155	Olympus Aspartate Aminotransferase Reagent	Olympus Corp.	CIT	Class II	1993-01-26
K925149	Auto Suture Endoscopic Knot Pusher	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-01-26
K925113	Olympus Uric Acid Reagent	Olympus Corp.	KNK	Class I	1993-01-26
K925110	Abbott Imx T4	Abbott Medical	CDX	Class II	1993-01-26
K924979	Immunocard(tm) C. Difficile	Meridian Diagnostics, Inc.	LLH	Class I	1993-01-26
K924815	Microplate Cannabinoids Assay	Solarcare Technologies Corp,Inc.	LDJ	Class II	1993-01-26
K924710	Triglycerides	Em Diagnostic Systems, Inc.	CDT	Class I	1993-01-26
K924488	Kodak Ektachem Clinical Chemistry Slides (Li)	Eastman Kodak Company	JIH	Class II	1993-01-26
K924149	Endo I/a Probe	Snowden-Pencer	GCJ	Class II	1993-01-26
K924078	Polydoros C	Siemens Medical Solutions USA, Inc.	IZO	Class I	1993-01-26
K923950	The Galileo Vega-24 Electroencephalograph	Biosound, Inc.	GWQ	Class II	1993-01-26
K923910	Heat Moisture Condenser	Concord/Portex	BYD	Class I	1993-01-26
K923334	Milne-Charkot Shott-Thur Cassette Holder	Cook, Inc.	IXA	Class II	1993-01-26
K922019	Laryngoscope Rigid	Eastmed Enterprises, Inc.	CCW	Class I	1993-01-26
K913940	Response(tm) Steerable Catheter	Daig Corp.	DRA	Class II	1993-01-26
K904999	Weingarten Tm Capnographic Intubation Stylette	Opticon Medical, Inc.	BSR	Class I	1993-01-26
K925729	Sd-602 Sd Mode 11, Sd-603 Sd Mod 111	Skylark Device Co., Ltd.	GZJ	Class II	1993-01-22
K925419	Passage Hemostasis Valve	Merit Medical Systems, Inc.	DTL	Class II	1993-01-22
K925262	Meridian Medical Systems Volume Ventilator Circuit	Merit Medical Systems, Inc.	CBK	Class II	1993-01-22
K925232	Meridian Medical Systems Adult Anes Breath Circuit	Merit Medical Systems, Inc.	CAI	Class I	1993-01-22
K925167	Mass Spectrometry Monitoring Line Cononectors	Merit Medical Systems, Inc.	CCK	Class II	1993-01-22
K924476	The Triage II	Biosite Incorporated	DKZ	Class II	1993-01-22
K924054	Phonocardiograph	Echo Ultrasound	DQC	Class I	1993-01-22