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 2594 of 3530

510(k) clearances, page 2594 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894998	Modified Posicam System Model 6.5	Positron	KPS	Class II	1989-11-02
K894980	Bio-Cal 370 Heater/cooler	Bio Medicus, Inc.	DWJ	Class II	1989-11-02
K894978	Bacterial Filter	Med-Tek Corp.	CAH	Class II	1989-11-02
K894292	Bard Liberator Disposable Infusion System	C.R. Bard Inc	FRN	Class II	1989-11-02
K895845	2018 Arterial/venous Pressure Dressing	Advance Medical Designs Inc	NAD	Class I	1989-11-01
K895457	Madayag, Manghini, Franseen, Green, Trocar Needles	Advance Medical Designs Inc	KNW	Class II	1989-11-01
K895320	Fluorovision Hr 2000 High Resolution Image Enhance	Digivision, Inc.	LLZ	Class II	1989-11-01
K895259	Pik Pocket(r), Model Pp-3	Teledyne Water Pik	EFS	Class I	1989-11-01
K894970	William Harvey Hf5000 Membrane Oxygenator	Medivators Inc	DTZ	Class II	1989-11-01
K894940	Datascope Steering Handle	Datascope Corp.	DQX	Class II	1989-11-01
K894239	Nanos	Biotronik Cardiac Pacemakers	DXY	Class III	1989-11-01
K893766	Lifecare Cont. Epidural Cath. for Morphine Sulfate	Abbott Medical	MAJ	Class II	1989-11-01
K893546	Optically Clear Radiopaque Catheter	Critikon Company, LLC	FOZ	Class II	1989-11-01
K892641	Bard Wm Harvey HF-5700 Memb Oxygen W/hardshell Res	Bard Cardiosurgery Div	DTZ	Class II	1989-11-01
K895950	Model Fel5100 Floor Light	F.W. Lang Co.	FSS	Class II	1989-10-31
K895891	Detectadot System 2000 Heterophile Test	Gull Laboratories, Inc.	KTN	Class II	1989-10-31
K895868	Heyer-Schulte Disposable Peritoneal Catheter Passe	Baxter Healthcare Corporation	GYK	Class I	1989-10-31
K895827	Innofluor Phenytoin Manual Fpia Reagent Set	Innotron of Oregon, Inc.	LGR	Class II	1989-10-31
K895765	Leeco Preview(r) Ebv (Eia)	Leeco Diagnostics, Inc.	KTN	Class II	1989-10-31
K895723	Irma-Count(tm) Pap, (Rkpa1, Rkpa2)	Siemens Healthcare Diagnostics Inc.	JFH	Class II	1989-10-31
K895706	Tubing Organizer	3t Products, Inc.	KNT	Class II	1989-10-31
K895575	Bio-Rad Modular Air Compressor	Bio-Rad	HKX	Class II	1989-10-31
K895475	Canon Auto Ref-Keratometer Rk-2	Canon Medical Components U.S.A., Inc.	HLQ	Class I	1989-10-31
K895438	S.m.p.u. Latex Examination Gloves	P.T. Surya Milani Plastic Utama	LYY	Class I	1989-10-31
K895415	Biopsy Forceps	Boston Scientific Corporation	EOQ	Class II	1989-10-31
K895396	Cyberfluor Fiagen Tsh	Cyberfluor, Inc.	JLW	Class II	1989-10-31
K895364	Lid Loc	Spectrum Co.	HOY	Class I	1989-10-31
K895288	Hva Eia Kit Yamasa	Yamasa Shoy Co., Ltd.	CDF	Class I	1989-10-31
K895252	Ultracision Ultrasonic Scalpel	Ultracision, Inc.	GEI	Class II	1989-10-31
K895250	Systemate(tm) Alkaline Phosphatase Item #65402	Em Diagnostic Systems, Inc.	CJE	Class II	1989-10-31
K895249	Systemate(tm) Iron Item Number: 65417	Em Diagnostic Systems, Inc.	JIY	Class I	1989-10-31
K895213	Microlase by Laser Trabeculoplasty	Keeler Instruments, Inc.	HQF	Class II	1989-10-31
K895141	Model 590 Oxygen Concentrator	Medtronic, Inc.	CAW	Class II	1989-10-31
K895094	Tandem-E Lh Immunoenzymetric Assay Kit	Hybritech, Inc.	CEP	Class I	1989-10-31
K895075	Acci-Guard Reusable Holder	Medical Safety Products, Inc.	FMI	Class II	1989-10-31
K895013	Cobo Temporary Keratoprosthesis	Ocular Instruments, Inc.	MLP	Class II	1989-10-31
K895005	Milenia(tm) Fsh (Mkfs1,5)	Siemens Healthcare Diagnostics Inc.	CGJ	Class I	1989-10-31
K894918	Horizon 2000 Fraction of Inspired Oxygen Mon. Cap.	Mennen Medical, Inc.	CCL	Class II	1989-10-31
K894859	Lp 400 Microplate Reader	Kallestad Diag, A Div. of Erbamont, Inc.	JJQ	Class I	1989-10-31
K894617	Olympus Pk-Tp System Reactive Control	Schiff & Co.	GMI	Class II	1989-10-31
K894552	'Med-Tech' Latex Examination Glove	Med-Tech Rubber & Engineering Industries	LYY	Class I	1989-10-31
K894513	Diathron(r) Diathermy Unit	Intl. Ophthalmic Industries Corp.	HJM	Class II	1989-10-31
K894449	Patient Examination Gloves	Pascorp Newmarket Sdn. Bhd.	LYY	Class I	1989-10-31
K894315	Restobond 3/Dentin-Enamel Bonding Agent	Lee Pharmaceuticals	KLE	Class II	1989-10-31
K894256	Sterile Surgeons Gloves	Chung Shiang Rubber Industrial Co.	KGO	Class I	1989-10-31
K894238	Abbott Tdx Total T3 Plus	Abbott Medical	CDP	Class II	1989-10-31
K894035	Eos Chemistry Analyzer	Eos Technology Corp.	JGS	Class II	1989-10-31
K893975	Double Antibody Glucagon	Siemens Healthcare Diagnostics Inc.	JME	Class I	1989-10-31
K893954	Cedia Cortisol Assay	Microgenics Corporation	JFT	Class II	1989-10-31
K893488	Pulsatile Pump for Gonadorelin Acetate	Ortho Pharmaceutical Corp.	FRN	Class II	1989-10-31