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 2026-10-26, 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 2731 of 3530

510(k) clearances, page 2731 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881052	Check Valve	Baxter Healthcare Corporation	FPA	Class II	1988-05-26
K881027	Msi 2002 Series Bed	Med Service, Inc.	FNL	Class II	1988-05-26
K880943	Microline Cat #100	Microline Pentax, Inc.	HQE	Class II	1988-05-26
K880860	Coronary Ostium Occluder, Catalog Code 32015	Dlp, Inc.	DQT	Class II	1988-05-26
K880850	Keith Nasogastric Sump Tube W/anti-Reflux Valve	Kmb Medical Products Co.	FEG	Class II	1988-05-26
K880802	Surgitek Articulating Ureteroscope Model Su-11	Medical Engineering Corp.	FGB	Class II	1988-05-26
K880801	Surgitek Flexible Ureteroscope Su-7 & Su-9	Medical Engineering Corp.	FGB	Class II	1988-05-26
K880605	Labeling Change for Cutter Pureflo Plus IV Filter	Miles Laboratories, Inc.	FPB	Class II	1988-05-26
K880102	Biasol Concentrates for Bicarbonate Dialysis	Baxter Healthcare Corporation	KPO	Class II	1988-05-26
K881949	Ats Nac-Pac Set	Alpha-Tec Systems, Inc.	JSK	Class I	1988-05-25
K881927	Prisma Tech 19 Gauge Disposable Extrusion Needles	Advanced Surgical Products, Inc.	HQE	Class II	1988-05-25
K881922	Cytojars Prefilled with Cytology Preservative	Surgipath Medical Industries, Inc.	LDZ	Class I	1988-05-25
K881882	Senographe 600T and 600Ts Senix HF	General Electric Co.	IZH	Class II	1988-05-25
K881712	Medtronic Model 5866-36 Lead Adaptor Kit	Medtronic, Inc.	DTB	Class III	1988-05-25
K881594	Sunglasses	Transfers Intl., Inc.	HQY	Class I	1988-05-25
K881508	Ochsner & Micron Fabric Patch	Intervascular, Inc.	DXZ	Class II	1988-05-25
K881491	Model 3487A Pisces Epidural Lead	Medtronic, Inc.	GZB	Class II	1988-05-25
K881419	Plastic Frame & Lens Sunglass	Marketing Innovations Intl., Inc.	HQY	Class I	1988-05-25
K881327	Stuart Cannulated Cancellous Bone Fixation Screw	Stuart Drug & Surgical Supply, Inc.	HWC	Class II	1988-05-25
K881278	Spectacle, Frame and Sunglasses	Nouvelle Ligne Paris	HQY	Class I	1988-05-25
K881184	Intertech Sterile Water for Inhalation	Delmed, Inc.	BTT	Class II	1988-05-25
K880991	Laser Optical Catheter System	MEDLINE INDUSTRIES, LP - Northfield	HHR	Class II	1988-05-25
K880929	Nidek Cv-4000	Nidek, Inc.	HQE	Class II	1988-05-25
K880231	Modified Pruitt Irrigation & Occlusion Catheter	Ideas for Medicine, Inc.	DQT	Class II	1988-05-25
K875337	Heparin Coated Luminal Pacing Catheter	Spectramed, LLC	DQO	Class II	1988-05-25
K875178	Model 435-04 Cardifix Side Hook Implant. Pace Lead	Intermedics, Inc.	DTB	Class III	1988-05-25
K874465	Sorenson Thermo. Flow-Direct Trans Pace Cath/lead	Abbott Medical	DYG	Class II	1988-05-25
K881870	Sharplan Nd:yag Surgical Hand Applicators	Sharplan Lasers, Inc.	GEX	Class II	1988-05-24
K881824	Laser Micromanipulator	Pfizer Laser Systems	GEX	Class II	1988-05-24
K881006	Stockert-Shiley Bubble Monitor 23-23-01	Shiley, Inc.	DRY	Class II	1988-05-24
K880887	Neocath	Taris Corp.	DWF	Class II	1988-05-24
K880777	8.5 Fr. Pescutaneous Sheath Introducer System	Medsurg Industries, Inc.	DWF	Class II	1988-05-24
K880763	Nezhat Irrigation Pump System	Cabot Medical Corp.	HET	Class II	1988-05-24
K875100	Model 438-03 Cardifix Side Hook Implant. Pace Lead	Intermedics, Inc.	DTB	Class III	1988-05-24
K863395	Wescor Sweat.chek Sweat Conductivity Analyzer	ELITechGroup Inc	CGZ	Class II	1988-05-24
K882012	Lifestyle Sof. Care Gel Chair Cushion	Gaymar Industries, Inc.	KNN	Class I	1988-05-23
K881590	Adfuse(tm)	Healthtek, Inc.	FRN	Class II	1988-05-23
K881515	Tear Volume Tests	Visionex, Inc.	KYD	Class I	1988-05-23
K881312	Laminaria	Busse Hospital Disposables	HDY	Class II	1988-05-23
K880499	Hemoccult Sensitive Test	Smithkline Diagnostics, Inc.	KHE	Class II	1988-05-23
K880469	Chlamydiazyme(tm)	Abbott Medical	LJC	Class I	1988-05-23
K880144	Stanbio Syphilis Rpr Test, No. 1170	Stanbio Laboratory	GMQ	Class II	1988-05-23
K875366	The Ddi Serodot Herpes Igg Test Kit	Disease Detection International, Inc.	GQO	Class II	1988-05-23
K875170	Ebna Antibody	Hillcrest Biologicals	LLM	Class I	1988-05-23
K881957	Hawkins-Akins Blunt Needle Access Kit	N-S Medical Products	KNW	Class II	1988-05-20
K881956	National-Standard Needle Holder	N-S Medical Products	KNW	Class II	1988-05-20
K881690	Port-a-Cath Portal Introducer Forceps	Pharmacia Deltec, Inc.	LKG	Class II	1988-05-20
K881493	Port-a-Cath Implantable Access System - Kit Conf.	Pharmacia Deltec, Inc.	LKG	Class II	1988-05-20
K881310	Dent Sleeve Manometric Catheter	Wilson-Cook Medical Inc.	KNT	Class II	1988-05-20
K880876	C-Stat/1000	Sonne Medical, Inc.	LHC	Class I	1988-05-20