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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2676 of 3530

510(k) clearances, page 2676 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884747	Technicon Chem 1 System Acid Phosphatase (Total)	Technicon Instruments Corp.	CKB	Class II	1989-01-30
K884745	Du Pont Aca Methotrexate Calibrator	E.I. Dupont de Nemours & Co., Inc.	DLJ	Class II	1989-01-30
K884744	Aca Du Pont Methotrexate (Mtho) Method	E.I. Dupont de Nemours & Co., Inc.	LAO	Unclassified	1989-01-30
K884725	Biasol Powder Concentrates for Bicarb. Dialysis	Baxter Healthcare Corporation	KPO	Class II	1989-01-30
K884637	Model 9550/9500 Respiration/heart Rate Monitor	Aequitron Medical, Inc.	BZQ	Class II	1989-01-30
K884233	Quadroject(tm)	Ellis Pharmaceutical Consulting, Inc.	FMF	Class II	1989-01-30
K884228	Cdi(r) 2000 Blood Gas Monitor	Cardiovascular Devices, Inc.	CBZ	Class II	1989-01-30
K883895	Dripride Ultra Incontinent Pad	Weyerhaeuser Co.	EYQ	Class I	1989-01-30
K883894	Dripride Provide Slim	Weyerhaeuser Co.	EYQ	Class I	1989-01-30
K883882	Humeral Locking Nail System	Howmedica Corp.	JDS	Class II	1989-01-30
K883718	Merit Hi-Flex(tm)	Merit Medical Systems, Inc.	FPK	Class II	1989-01-30
K883430	Pregna-Card(tm) a Visual Home Pregnancy Test	Disease Detection International, Inc.	LCX	Class II	1989-01-30
K883090	Minicap Tm 100 Capnometer	Minesafety Appliances Co.	CCK	Class II	1989-01-30
K875130	Bone Nail W/washer & an Arthroscopic Insertion Sys	Mizuho Orthopedic Systems Inc	HRX	Class II	1989-01-30
K890264	Strabismus Scissors	Kinetic Medical Products	LRW	Class I	1989-01-27
K890263	Cilia Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890262	Lung Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890261	Trigeminal Scissors	Kinetic Medical Products	HRR	Class I	1989-01-27
K890260	Bone Shears	Kinetic Medical Products	HTD	Class I	1989-01-27
K890259	Rib Shears	Kinetic Medical Products	HTD	Class I	1989-01-27
K890258	Bone Cutting Forceps, Single-Action	Kinetic Medical Products	HTD	Class I	1989-01-27
K890257	Bone Cutting Forceps, Double-Action	Kinetic Medical Products	HTD	Class I	1989-01-27
K890256	Bone Rongeur, Double-Action	Kinetic Medical Products	EMH	Class I	1989-01-27
K890255	Bone Rongeur, Single-Action	Kinetic Medical Products	EMH	Class I	1989-01-27
K890253	Surgical Elevator	Kinetic Medical Products	GEG	Class I	1989-01-27
K890252	Bone Curette	Kinetic Medical Products	HTF	Class I	1989-01-27
K890250	Surgical Wire Cutters	Kinetic Medical Products	GAD	Class I	1989-01-27
K890248	Surgical Retractors	Kinetic Medical Products	GAD	Class I	1989-01-27
K890247	Surgical Retractors	Kinetic Medical Products	GAD	Class I	1989-01-27
K890246	Artery Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890245	Surgical Hemostats	Kinetic Medical Products	HRQ	Class I	1989-01-27
K890244	Tubing Clamp Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890243	Dressing Forceps	Kinetic Medical Products	EFL	Class I	1989-01-27
K890242	Scalpel Handle	Kinetic Medical Products	GDZ	Class I	1989-01-27
K890238	Catheter Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890234	Suture Clip Remover	Kinetic Medical Products	HTD	Class I	1989-01-27
K890233	Suture Clip Applier/remover	Kinetic Medical Products	GDO	Class I	1989-01-27
K890231	Surgical Towel Clips	Kinetic Medical Products	HBR	Class I	1989-01-27
K890230	Ligature Needles	Kinetic Medical Products	GEG	Class I	1989-01-27
K890229	Surgical Needle Holders	Kinetic Medical Products	GDF	Class I	1989-01-27
K890228	Surgical Needle Guide	Kinetic Medical Products	GDF	Class I	1989-01-27
K890227	Surgical Probe	Kinetic Medical Products	HXB	Class I	1989-01-27
K890226	Surgical Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27
K890225	Surgical Scissors	Kinetic Medical Products	HRR	Class I	1989-01-27
K890221	Microsurgical Wire Loop	Kinetic Medical Products	JYQ	Class I	1989-01-27
K890218	Microsurgical Cystotome	Kinetic Medical Products	KOA	Class I	1989-01-27
K890217	Microsurgical Knives	Kinetic Medical Products	EMF	Class I	1989-01-27
K890215	Microsurgical Scarifier	Kinetic Medical Products	EMF	Class I	1989-01-27
K890214	Microsurgery Razor Blade Holder	Kinetic Medical Products	EMF	Class I	1989-01-27
K890213	Microsurgical Forceps	Kinetic Medical Products	HTD	Class I	1989-01-27