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 2026-10-08, 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 3456 of 3526

510(k) clearances, page 3456 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780274	Influenza Hi Antiserum	Flow Laboratories, Inc.	GNS	Class I	1978-02-28
K780273	Influenza Hi Preserum	Flow Laboratories, Inc.	GNS	Class I	1978-02-28
K780272	Influenza Ha Antigen	Flow Laboratories, Inc.	GNT	Class I	1978-02-28
K780266	Bone Cement Applicator	Zimmer GmbH	KIH	Class I	1978-02-28
K780250	Hemopexin Nephelometric Assays	Kallestad Laboratories, Inc.	CZX	Class II	1978-02-28
K780230	Bed Board	Zimmer GmbH	FPS	Class I	1978-02-28
K780075	Rialyze Digoxin	Miles Laboratories, Inc.	DPG	Class II	1978-02-28
K772327	Las-R Human Igd Test	Hyland Therapeutic Div., Travenol Laboratories	CZJ	Class II	1978-02-28
K772153	Flame Photometer Standard	Alko Scientific Co.	JIT	Class II	1978-02-28
K780287	Day Hear Hook	Edward Weck, Inc.	JYL	Class I	1978-02-27
K780270	Computer Audiometer - Ma26	Maico Hearing Instruments, Inc.	EWO	Class II	1978-02-27
K780269	Computer Audiometer - Ma25	Maico Hearing Instruments, Inc.	EWO	Class II	1978-02-27
K780247	Impco Disposable Aortic Punch	Thoratec Laboratories Corp.	DWS	Class I	1978-02-27
K780240	Predictor	Organon LLC	LCX	Class II	1978-02-27
K780296	Therapy Scooter	Convaid Product Development	KNL	Class I	1978-02-24
K780268	Bladder Cath Kit W/out Catheter	Latex Ind., Inc.	FCM	Class II	1978-02-24
K780267	Cath Tray W/out Catheter	Latex Ind., Inc.	EYZ	Class I	1978-02-24
K780225	Orthosises Devices	Zimmer GmbH	IQI	Class I	1978-02-24
K780116	Amplifier, Pc-700	Burdick Corp.	DQC	Class I	1978-02-24
K780037	Exerciser, Resp., Deep Breathing	Medical Technologies of Georgia	BWF	Class II	1978-02-24
K772342	Robinson Kit - 750014 & 750016	Latex Ind., Inc.	FCM	Class II	1978-02-24
K772341	Bladder Kit - 734000	Latex Ind., Inc.	FCM	Class II	1978-02-24
K772340	Catheterization Kit 732016-732018	Latex Ind., Inc.	FCM	Class II	1978-02-24
K780257	Microspears	Sparta Instrument Corp.	HOZ	Class II	1978-02-23
K780235	Orthopedic Devices	Zimmer GmbH	HWC	Class II	1978-02-23
K780234	Traction Belt, Pelvic	Zimmer GmbH	ILZ	Class I	1978-02-23
K780233	Traction Weight Bags	Zimmer GmbH	HST	Class I	1978-02-23
K780228	Traction Units	Zimmer GmbH	HST	Class I	1978-02-23
K780207	Liquisol Digoxin Ria Test Kit	Damon Corp.	DON	Class II	1978-02-23
K780179	Liquid Scintillation Counter	Roche Medical Electronics, Inc.	JJJ	Class I	1978-02-23
K780174	Orabrite	Norcliff Thayer, Inc.	JER	Class I	1978-02-23
K780156	Spectrophotometer, Model 380	Turner Assoc.	JJQ	Class I	1978-02-23
K780147	Isoenzyme Serum Control	Corning Medical & Scientific	JJT	Class I	1978-02-23
K780146	T3 Sti Kit	Polysciences, Inc.	KHQ	Class II	1978-02-23
K780118	Electrode, Dispersive, Disp. Neopad	Halyard Health	HAM	Class II	1978-02-23
K780232	Restraint, Protective	Zimmer GmbH	FMQ	Class I	1978-02-21
K780231	Bandage, Elastic	Zimmer GmbH	FQM	Class I	1978-02-21
K780206	Generator, Electrosurgical	Medtronic, Inc.	GEI	Class II	1978-02-21
K780202	Monomer Evacuation System	Medishield, Inc.	JDY	Class I	1978-02-21
K780197	Hearing Aid, Body Worn	Oticon, Inc.	ESD	Class I	1978-02-21
K780190	Catheter Strap & Ruinary Bay Holder	Baka Manufacturing Co., Inc.	FAQ	Class I	1978-02-21
K780181	Gloves, Floor	Tillotson Rubber Co., Inc.	FML	Class I	1978-02-21
K780167	Cath Kit, Urine Specimen	C.R. Bard Inc	FMH	Class I	1978-02-21
K780166	Stress Test System	Quinton, Inc.	DPS	Class II	1978-02-21
K780130	Burette Intravenous Admin. Sets.	Y	FPA	Class II	1978-02-21
K780124	Catheterization Proced. Tray, Urethral	Walpak Co.	FCM	Class II	1978-02-21
K780123	Catheterization Procedure Tray	Walpak Co.	FCM	Class II	1978-02-21
K780106	Parenteral Infusion Controller, Elec.	National Patent Development Corp.	FLN	Class II	1978-02-21
K780105	Needle Connecting Set, Blunt	Abbott Medical	FOZ	Class II	1978-02-21
K780057	Urine Sample Collection Kit	C.R. Bard Inc	FMH	Class I	1978-02-21