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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3128 of 3528

510(k) clearances, page 3128 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832809	Accu-Prep Programmable Auto-Diluter	Beckman Instruments, Inc.	JQW	Class I	1983-10-27
K832549	Solution Admin. Line W/spike	Vascular Specialties, Inc.	FPA	Class II	1983-10-27
K832500	Cs-11	Chema-Scutum, Inc.	EBE	Class II	1983-10-27
K832453	Slimb Single Limb Breathing Circuit	Respiratory Care, Inc.	CAI	Class I	1983-10-27
K832221	Ybbott Cmv Total Ab Eia	Abbott Medical	LFZ	Class II	1983-10-27
K832164	Coat-a-Count Free T3 Ria Kit	Siemens Healthcare Diagnostics Inc.	CDP	Class II	1983-10-27
K832067	Share Int'l Tdm	Share Int'L	HCJ	Class II	1983-10-27
K831860	Generator, Pulse, Pacemaker #532	Vitatron Medical BV	DXY	Class III	1983-10-27
K831859	Pacemaker Programmer #2032	Vitatron Medical BV	DXY	Class III	1983-10-27
K831825	Dispos. Hyperbaric Oxygen Cush/traum	Hospitak, Inc.	KPJ	Class II	1983-10-27
K831711	Cmv Igm Test	Gull Laboratories, Inc.	LKQ	Class II	1983-10-27
K831274	Wlectrocardiograph ECG-7204	Nihon Kohden America Inc	DSI	Class II	1983-10-27
K830568	Guttman Infusion Needle	Cosmetic Sciences, Inc.	FMI	Class II	1983-10-27
K832041	Servomed Standard Sms 104	Litton Medical Electronics	DRT	Class II	1983-10-26
K832026	Servomed Basic Bedside Unit Sms 108 W/	Litton Medical Electronics	DRT	Class II	1983-10-26
K832024	Servomed Basic Bedside Unit - Various	Litton Medical Electronics	DRT	Class II	1983-10-26
K832016	Lme Heart-Rate Monitor	Litton Medical Electronics	DRT	Class II	1983-10-26
K833130	Tri-Count 7	Hematology Marketing Assoc.	JPK	Class II	1983-10-20
K833114	Oxford Mark 2 External Fixator	Johnson & Johnson Professionals, Inc.	JEC	Class II	1983-10-20
K833106	Biotronik Dfh Unipolar Pe-60/4-Dfh	Biotronik Sales, Inc.	DTB	Class III	1983-10-20
K833099	Biotronik N, Bipolar Peb-60/4-N	Biotronik Sales, Inc.	DTB	Class III	1983-10-20
K833048	Purges Lines, Pl-45 & Pl-33	American Bentley	DTM	Class II	1983-10-20
K832987	Permanthane #866 Bipolar Coaxial	Pacesetter Systems	DTB	Class III	1983-10-20
K832884	Fixation Staple Driver/extractor	Warsaw Orthopedic, Inc.	JDR	Class II	1983-10-20
K832784	Ultra Light Raaf Catheter	Quinton, Inc.	DQY	Class II	1983-10-20
K832604	Physiological Pressure Measurement Cath	Camino Laboratories, Inc.	DXO	Class II	1983-10-20
K832579	Physiological Press. Measurement Cath	Camino Laboratories, Inc.	DXO	Class II	1983-10-20
K832528	Mgi Strength/fitness Sys-Model #Pu-101	Mgi Strength/Fitness Systems, Inc.	JOM	Class II	1983-10-20
K832521	Plastic Suction Tips	Wells Johnson Co.	GEA	Class I	1983-10-20
K832520	Suction Tips	Wells Johnson Co.	GEA	Class I	1983-10-20
K832519	Aspirating Tubing	Wells Johnson Co.	GAZ	Class II	1983-10-20
K832467	Portable Lifecare Ventilator Plv-100	Lifecare Services, Inc.	CBK	Class II	1983-10-20
K832458	Automatic Endoscope	American Endoscopy, Inc.	NVE	Class II	1983-10-20
K832428	Platelet Aggregation Reagent Set	Helena Laboratories, Corp.	GHR	Class II	1983-10-20
K832417	Hypothermic Mycardial Protection Dev	3M Health Care, Sarns	DTR	Class II	1983-10-20
K832395	Holta-Med Recorder	Holta-Med	DSH	Class II	1983-10-20
K832328	Intramedullary Bone Plug	Kirschner Medical Corp.	JDS	Class II	1983-10-20
K832274	Aspirator	Wells Johnson Co.	BTA	Class II	1983-10-20
K832116	Atac 4700 Hematology Cell Counter	Turpen Laboratory Systems, Inc.	GIF	Class I	1983-10-20
K832043	Surgikek Penile Prosthesis Tail Extend	Medical Engineering Corp.	FAE	Class II	1983-10-20
K831997	Implantable Endocardial Pacing Leads	Oscor Inc.	DTB	Class III	1983-10-20
K831894	Blood Oxygenator 5070	Shiley, Inc.	DTZ	Class II	1983-10-20
K831854	Usci Angiographic Balloon Catheter	C.R. Bard Inc	DYG	Class II	1983-10-20
K831804	Multipolar Temporary Cardiac	Oscor Inc.	LDF	Class II	1983-10-20
K831751	Lead Introducer Sets-Eb-S8 & Eb-S12	Oscor Inc.	DYB	Class II	1983-10-20
K831695	Temp. Cardiac Pacing Wire Tme 60/61/65	Oscor Inc.	LDF	Class II	1983-10-20
K831458	Cardioplegia Recirculation Sys-Bl 705/A	Electromedics, Inc.	DWB	Class II	1983-10-20
K830667	Silicone-Silver Penile Prosthesis-Esk	Dacomed Corp.	FTQ	Class II	1983-10-20
K833247	Quantaphase B-12-Cobalmin-Folate-	Bio-Rad	CDD	Class II	1983-10-19
K833242	Deflecting Guide Wire	Van-Tec, Inc.	KNY	Class II	1983-10-19