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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3503 of 3526

510(k) clearances, page 3503 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K761348	Cervical-Vaginal Spatula	Law Offices of Natter & Natter	HHT	Class II	1977-01-18
K761347	Colposcopically Directed Ob/gyn Laser	Photon Sources	HHR	Class II	1977-01-18
K770021	Mask, Face, Surgical	Precept, Inc.	CAD	Class II	1977-01-17
K761183	Lysing Agent Af	Central Labs. Assoc. MD Pathologists	JCE	Class I	1977-01-17
K760952	Terasaki Lymphocyte Transport Kit	Dravon Medical, Inc.	KSR	Class II	1977-01-17
K770064	Fluoride Gel Disposable Tray	Lorvic Corp.	KMT	Class I	1977-01-14
K770063	Disp. Absorbent Compressed Fibre Wafer	Lorvic Corp.	EFN	Class I	1977-01-14
K770061	Vo Respiratory Pneumotachograph	Research Development Corp.	JAX	Class II	1977-01-14
K770059	Orthopedic Specialties	Robert R. Moore			1977-01-14
K770055	Composite Restorative Material, Prestige	Lee Pharmaceuticals	EBF	Class II	1977-01-14
K770052	Vital-Lok Tracheal Swivel Coupling	V.F.P. Corp.	BZA	Class I	1977-01-14
K770048	Dnc 162 Vinca-Flo	Sorensen Research	KOC	Class II	1977-01-14
K770047	Dnc 151 Vinca-Flo	Sorensen Research	FJT	Class II	1977-01-14
K770046	Dnc 142 Vinca-Flo	Sorensen Research	KOC	Class II	1977-01-14
K770045	Dnc 152 Vinca-Flo	Sorensen Research	KOC	Class II	1977-01-14
K770044	Dnc 141 Vinca-Flo	Sorensen Research	KOC	Class II	1977-01-14
K770043	Dnc 161 Vinca-Flo	Sorensen Research	KOC	Class II	1977-01-14
K770041	Scissors, Strabismus, 4 Curved	J. Sklar Mfg. Co., Inc.	HNF	Class I	1977-01-14
K770040	Scissors, Strabimus, 4 Straight	J. Sklar Mfg. Co., Inc.	HNF	Class I	1977-01-14
K770038	Monitor, Heartwatch Heart Rate	Respironics, Inc.	DRT	Class II	1977-01-14
K770037	Electrocardiograph Model 344	Birtcher Corp.	DPS	Class II	1977-01-14
K770036	Cardiotomy Reservoir	Shiley, Inc.	DTN	Class II	1977-01-14
K770035	Screw, Wadsworth Olecranon	Orthopedic Equipment Co., Inc.	HWC	Class II	1977-01-14
K770018	Pacing Kit, Semi-Floating	Electro-Catheter Corp.	DTR	Class II	1977-01-14
K770017	Pacing Kit, Transmyocardial	Electro-Catheter Corp.	DTR	Class II	1977-01-14
K770016	Pacing Kit, Elecath Transthoracic	Electro-Catheter Corp.	DTR	Class II	1977-01-14
K770004	P.r.a.s. Cary & Blair Transport Medium	Scott Laboratories, Inc.	JSJ	Class I	1977-01-14
K761359	Neomycin Agar with 5% Sheep Blood	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1977-01-14
K761231	Model 738 Birt-a-Pad	Birtcher Corp.	GEI	Class II	1977-01-14
K761226	Gp3%sp-2100Dohon100/120 Mesh Supelcoport	Supelco, Inc.	JSQ	Class I	1977-01-14
K760777	Colon-X	Carlton Hygienics, Inc.	FCE	Class I	1977-01-13
K760616	Propioceptor Massager	Cellers Research, Inc.	ISA	Class I	1977-01-13
K770042	Adapter, Lead, General Electric	Cardiac Pacemakers, Inc.	DTD	Class II	1977-01-12
K770032	Page Turner	Possum, Inc.	ILP	Class I	1977-01-12
K770031	Alarm Intercom Door Lock	Possum, Inc.	ILQ	Class II	1977-01-12
K770030	Alarm, Commun.-Sec. Indep.-Emer.	Possum, Inc.	ILQ	Class II	1977-01-12
K770029	Typewriter Control Systems	Possum, Inc.	ILQ	Class II	1977-01-12
K770028	Environmental Control Systems	Possum, Inc.	IQA	Class II	1977-01-12
K770019	Scissors, Iris	J. Sklar Mfg. Co., Inc.	HNF	Class I	1977-01-12
K770001	Airway, Berman 40, 60, 80, 90, L00mm's	Omnicon Medical Corp.	CAE	Class I	1977-01-12
K761338	Leff Stethoscope for Fetal Heart	J. Sklar Mfg. Co., Inc.	HGN	Class I	1977-01-12
K761323	Surgical Marking Pen	Richard-Allan Medical Ind., Inc.	FZZ	Class I	1977-01-12
K761273	Flushflo-Model Cc1-6	Bentley Laboratories, Inc.	KRA	Class II	1977-01-12
K761221	Non-Sterile Pregelled Grounding Pad	Ipco Corp.	GEI	Class II	1977-01-12
K761204	Barrier Impervious Back Table Cover	Surgikos, Inc.	KKX	Class II	1977-01-12
K761201	Echo-Cardiotrace, Automatic	The Metrix Company	HGM	Class II	1977-01-12
K761193	Suture Removal Kit	Superior Plastic Products Corp.	KDD	Class I	1977-01-12
K761086	Reagents	Simmler & Son, Inc.	JJC	Class I	1977-01-12
K761007	Artificial Kidney, C-Dak Cordis Dow	Cordis US Corp.	FJI	Class II	1977-01-12
K760975	Weil Oncometer (Il 186)	Instrumentation Laboratory Co.	JJK	Class I	1977-01-12