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 2026-10-12, 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 3336 of 3528

510(k) clearances, page 3336 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802025	Balloon Retention Chest Catheter	Loseff Medical Designers, Ltd.	GBA	Class I	1980-09-26
K802007	Pediwet=guaze Impregnated with Petrol	Pollak (Intl.).ltd	FRQ	Class II	1980-09-26
K801988	Nordiclab Prostatic Acid Phosphatase Ria	Nordiclab Intl.	JFH	Class II	1980-09-26
K801978	Programalith #'S 221, 222, 221A & 222A	Pacesetter Systems	DXY	Class III	1980-09-26
K801976	Scanlan Sternum Needle-Suture	Scanlan Intl., Inc.	GAB	Class I	1980-09-26
K801968	Hemocath I Kidney Dialysis Catheter	Medical Components, Inc.	LBW	Class II	1980-09-26
K801967	Medcomp Femoral Vein Catheter	Medical Components, Inc.	FIF	Class II	1980-09-26
K801966	Hemo-Cath II Kidney Dialysis Catheter	Medical Components, Inc.	FIE	Class II	1980-09-26
K801957	Micro-Flow Spectrophotometer Cl-720	Shimadzu Precision Instruments, Inc.	JJQ	Class I	1980-09-26
K801951	Api-Cts Streptococcus	Analytical Products, Inc.	JTO	Class I	1980-09-26
K801948	Digital Subtraction Radiography System	Technicare Corp.	JAA	Class II	1980-09-26
K801939	Rhytidometer	Aztec Medical Products, Inc.	FTY	Class I	1980-09-26
K801913	Microlab M-Microprocessor Diluter/disp	Hamilton Co	JQW	Class I	1980-09-26
K801909	Lsa 290 Assay Reagents/nephelometric	J.T. Baker Chemical Co.	DEX	Class I	1980-09-26
K801899	Keithley Lymphocyte Depletion Cart	Keithley Development Co.	KDK	Class II	1980-09-26
K801889	Model 203S Clinical Chemistry Analyzer	Gilford Instrument Laboratories, Inc.	JJE	Class I	1980-09-26
K801827	Renaflo Hollow Fiber Dialyzer #100.1	Renal Systems, Inc.	FJI	Class II	1980-09-26
K801826	Renaflo Hollow Fiber Dialyzers #Mp 140	Renal Systems, Inc.	FJI	Class II	1980-09-26
K801825	Renaflo Hollow Fiber Dialyzers S.m.a.d.	Renal Systems, Inc.	FJI	Class II	1980-09-26
K801808	Br 2002 X-Ray Generator System	Valmet Indus. Mach. & Prod., Inc.	IZO	Class I	1980-09-26
K801728	Embria-Ck	Intl. Immunoassay Laboratories, Inc.	JHX	Class II	1980-09-26
K801699	Ethicon Retraction Tape	Ethicon, Inc	GAD	Class I	1980-09-26
K801656	Edp 1200 Sector Scanner Option	Unirad Corp.	IYN	Class II	1980-09-26
K801655	Auto Sector Scanner	Unirad Corp.	IYN	Class II	1980-09-26
K801501	UV Uric Acid Standards	The Dow Chemical Co.	JIS	Class II	1980-09-26
K801451	Isonephros-Pediatric, Standard, Optimum	Medical, Inc.	FJG	Class II	1980-09-26
K801306	Clinetics Pca Column	Clinetics Corp.	DHX	Class II	1980-09-26
K801063	Hall Arterial Oscillator	American Sterilizer Co.	DWX	Class II	1980-09-26
K800944	Medtronic Model 69575	Medtronic, Inc.	DTB	Class III	1980-09-26
K800857	Helena Glycosylated Hemoglobin Quik Meth	Helena Laboratories, Corp.	LCP	Class II	1980-09-26
K800519	Heartwatch	D. Jenkins	DRT	Class II	1980-09-26
K800379	Bifocal 2 8200 Series (A,b C,d)	American Pacemaker Corp.	DXY	Class III	1980-09-26
K792377	Carcinoembryonic Antigen (Cea) Control	Environmental Chemical Specialties	DHX	Class II	1980-09-26
K802354	Prophylactic W/spermicidal Lubricant	Schmid Laboratories, Inc.			1980-09-25
K801537	Start It with & without i.v. Cath. Unit	Pioneer Viggo, Inc.	FOZ	Class II	1980-09-19
K800793	Implantable Program. Cardiac Pacemaker	Telectronics, Inc.	DXY	Class III	1980-09-18
K802208	Leukocyte Vol. Analysis Apparatus	Coulter Electronics, Inc.	GKL	Class II	1980-09-17
K802262	Composite Restorative	L.D. Caulk Co.			1980-09-16
K802147	Shiley Temperature Monitor	Shiley, Inc.	FLL	Class II	1980-09-16
K802127	Bacitracin Differentiation Disc	Biomedia, Inc.	JTO	Class I	1980-09-16
K802125	Anterior/posterior Composite Restorative	Dentsply Intl.	EBF	Class II	1980-09-16
K802123	Monospherical Shoulder Prosthesis	Howmedica Corp.	HSD	Class II	1980-09-16
K802119	Shiley Utility Reservoir	Shiley, Inc.	DTN	Class II	1980-09-16
K802105	C-Blade	Cutter Laboratories, Inc.	HWE	Class I	1980-09-16
K802104	C-Splint	Cutter Laboratories, Inc.	IQI	Class I	1980-09-16
K802101	i.v. Sentry Alarm Device	Pike Medical Co.	FLN	Class II	1980-09-16
K802100	Intracranial Pressuring Monitoring Syst.	Pudenz-Schulte Medical Research Corp.	GWM	Class II	1980-09-16
K802083	Catheter Insertion Tray	Walpak Co.	KOD	Class II	1980-09-16
K802079	Deknatel Goosen Vascular Punch Blades	Howmedica Corp.	DWS	Class I	1980-09-16
K802075	Hollow Fiber Dialyzer Holder	Renal Devices, Inc.	FKI	Class II	1980-09-16