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 2205 of 3531

510(k) clearances, page 2205 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931993	Iti Distance System	Straumann USA, LLC	DZE	Class II	1994-04-26
K931520	Epstein-Barr Virus Vca (Igm) Recomb Immun Antibody	Mrl Diagnostics	LJN	Class I	1994-04-26
K930495	Panoject Minifusor Model 200 Ambu. Infusion Pump	Elan Medical Technologies, Ltd.	FRN	Class II	1994-04-26
K930494	Panoject Minifusor Model 100 Ambulatory Infusion	Elan Medical Technologies, Ltd.	FRN	Class II	1994-04-26
K924392	Cardiac T Elisa Troponin-T	Boehringer Mannheim Corp.	MMI	Class II	1994-04-26
K924322	Flow=med	International Electronic Technology Corp.	BZH	Class II	1994-04-26
K920301	Pace 2 Neisseria Gonorrhoeae Probe Confirm. Assay	Hologic, Inc.	LSL	Class II	1994-04-26
K912529	Ergomed	Kryoderm USA, Inc.	GEH	Class II	1994-04-26
K940946	Guangzhou Dashin Optics ENT.	Guangzhou Dashin Optics Enterprise, Ltd.	HQY	Class I	1994-04-25
K940428	Innerdyne Single-Stick Radially Expanding Dilator	Innerdyne Medical, Inc.	GCJ	Class II	1994-04-25
K940157	Enline Monopolar Endoscopic Surgical Instruments	Surgigus Instruments, Inc.	GCJ	Class II	1994-04-25
K936114	Birtcher Pericardial Knives	Birtcher Medical Systems, Inc.	GCJ	Class II	1994-04-25
K935753	The Graftologer	Neoligaments, Ltd.	HWE	Class I	1994-04-25
K935071	Insulated Forceps, Biopsy Forceps, Scissors	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-04-25
K935031	Riza-Ribe Needle	R-Med, Inc.	HET	Class II	1994-04-25
K934616	Cancellous Bone Screw	Onyx Medical LLC	HWC	Class II	1994-04-25
K934615	Cancellous Bone Screw	Onyx Medical LLC	HWC	Class II	1994-04-25
K934538	MRI Resonance Diagnostic Device Accesory	Noise Cancellation Technologies	LNH	Class II	1994-04-25
K934432	Otoview Endoscopy System	Smith & Nephew Richards, Inc.	EWA	Class I	1994-04-25
K934413	Kodak Ektachem Clinical Chemistry Slide for Asparate Amimotransferase	Eastman Kodak Company	CIT	Class II	1994-04-25
K934353	Zirconium Alloy Uni-Polar Head	Smith & Nephew Richards, Inc.	KWL	Class II	1994-04-25
K934126	One and Two Piece Temporary Healing,(emergence Profile) Abutments	ZimVie US Corp LLC	DZE	Class II	1994-04-25
K934106	Kodak Ektachem Dtsc II Slides (Li)	Eastman Kodak Company	JIH	Class II	1994-04-25
K932997	Microprep Cavity Preperation System	Sunrise Technologies, Inc.	KOJ	Class II	1994-04-25
K932987	Birtcher Laparoscope and Accessories	Birtcher Medical Systems, Inc.	GCJ	Class II	1994-04-25
K932728	Kodak Ektachem Clinical Chemistry Slides (Uric)	Eastman Kodak Company	KNK	Class I	1994-04-25
K931790	Cortical Bone Screw	Onyx Medical LLC	HWC	Class II	1994-04-25
K931771	Birtcher Endoscopic Corkscrew	Birtcher Medical Systems, Inc.	HET	Class II	1994-04-25
K931694	1/4 Tubular Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931693	1/3 Tubular Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931691	Straight Mini-Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931689	Small Straight Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931688	Semi-Tubular Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931687	Multiple Fragment Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931685	Forearm Self Compression Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931683	Cloverleaf Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931681	Cannulated Navicular Screw	Onyx Medical LLC	HWC	Class II	1994-04-25
K931679	Buttress Plate	Onyx Medical LLC	HRS	Class II	1994-04-25
K931654	Birtcher Magnetic Retriever (Gs-3100)	Birtcher Medical Systems, Inc.	HET	Class II	1994-04-25
K930966	Baumer Plates	Baumer Ortopedia, Ltd.	HRS	Class II	1994-04-25
K930887	Birtcher Bronchus & Lung Clamp (Gs-1620 & Gs-1600)	Birtcher Medical Systems, Inc.	GCJ	Class II	1994-04-25
K930806	Zymed Holter Scanner Model 2010	Agilent Technologies, Inc.	DQK	Class II	1994-04-25
K923951	Cd8 Cytospheres Kit	Coulter Electronics, Inc.	MAM	Class II	1994-04-25
K941494	Endo-Assist Laparoscopic Instruments	Sharpe Endosurgical Corp.	HET	Class II	1994-04-22
K941466	Surgical Instruments Kit	Clinical Resources, Inc.	FRG	Class II	1994-04-22
K941465	Suture Removal Kit	Clinical Resources, Inc.	MCZ	Class I	1994-04-22
K941399	Operating Microscope Aa Om 10	Appasamy Associates (U.S.A.), Inc.	FSO	Class I	1994-04-22
K941365	Mpi Denture Adhesive Film Seals	Medical Polymers, Inc.	KOT	Class I	1994-04-22
K941316	Brimfield Precision Fan Retractor	Springfield Surgical Instruments	GCJ	Class II	1994-04-22
K940999	Prodigit 2000	Calmed Technology, Inc.	EWO	Class II	1994-04-22