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 3102 of 3528

510(k) clearances, page 3102 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834460	Model 1888 Alpha Cos/respiration Car	Spacelabs, Inc.	LLK	Class II	1984-02-13
K834393	Deseret Neonatal Catheter Set	Parke-Davis Co.	FOZ	Class II	1984-02-13
K834334	Medaid Dual Channel TENS	Par Medex, Ltd.	GZJ	Class II	1984-02-13
K834298	Unicondylar Fiber Metal Knee	Zimmer GmbH	HRY	Class II	1984-02-13
K834271	Reflocheck & Glucose Test Strip Sys	Boehringer Mannheim Corp.	CGA	Class II	1984-02-13
K834251	Hdl Cholesterol Pretreatment	American Monitor Corp.	LBR	Class I	1984-02-13
K834225	Raaf Dual Lumen Cath. Repair Kit 2.2	Quinton, Inc.	LJS	Class II	1984-02-13
K834223	Cardiovascular Spring Guide Wire	Mallinckrodt Critical Care	DQX	Class II	1984-02-13
K834125	Chlamydial Transport Medium	Bartels Immunodiagnostic Supplies, Inc.	JSM	Class I	1984-02-13
K834122	Chlamydiae Isolation Medium W/cyclohex	Bartels Immunodiagnostic Supplies, Inc.	KIT	Class I	1984-02-13
K833654	Ids Rapid Str System	Innovative Diagnostic Systems, Inc.	JTO	Class I	1984-02-13
K833363	Cloutier II Fiber Metal Total Knee	Zimmer GmbH	JWH	Class II	1984-02-13
K832999	Respiration Monitor	Litton Medical Electronics	FLS	Class II	1984-02-13
K832487	Draw Sheet, Anti-Microbial	American Threshold Industries, Inc.	KME	Class I	1984-02-13
K832486	Pillow Cover, Anti-Microbial	American Threshold Industries, Inc.	KME	Class I	1984-02-13
K840604	Dsp-200 Digital Stethoscope	William K. Hagan			1984-02-10
K840349	Mark III Resuscitator	Ambu, Inc.	BTM	Class II	1984-02-10
K840346	Neuromusclar II	Mentor	IPF	Class II	1984-02-10
K840175	Double Lumen Infusion Catheters	Medical Components, Inc.	DQY	Class II	1984-02-10
K840103	Radioimmunoassay for Total Ige Human	Techniclone Intl.	JHR	Class II	1984-02-10
K840087	Preserv Gomori Trichrome Stain 125/500	Preventive Diagnostics Corp.	LED	Class I	1984-02-10
K840056	Pediatric Intubation Circuit	Ackrad Laboratories	CAI	Class I	1984-02-10
K840049	Sopheia Mp Igm Rheumatoid Factor Eia	Siemens Healthcare Diagnostics Inc.	DHR	Class II	1984-02-10
K840043	Sdi Prepax Dilukit CT	Scientific Distributors, Inc.	GIF	Class I	1984-02-10
K840042	Sdi Prepax Dilukit Ca	Scientific Distributors, Inc.			1984-02-10
K840040	Health-Up	Kung-Ho International, Inc.	GZJ	Class II	1984-02-10
K840038	Prepax Dilukit Plus	Scientific Distributors, Inc.	GIF	Class I	1984-02-10
K840019	K-Tube Repair Kit	Midwest Metabolic Support Group	KNT	Class II	1984-02-10
K834598	Light Test	Hemogenetics, Inc.	DHB	Class II	1984-02-10
K834594	Total Ige Fast Test	Allergenetics	DGC	Class II	1984-02-10
K834580	Reach* Toothbrush	Johnson & Johnson Professionals, Inc.	EFW	Class I	1984-02-10
K834568	Coulter Counter M2	Coulter Electronics, Inc.	GKL	Class II	1984-02-10
K834554	Ethox Weighted Feeding Tube	Ethox Corp.	KNT	Class II	1984-02-10
K834523	Model M410d Hearing Aid	Radioear Corp.	ESD	Class I	1984-02-10
K834489	Ultrospec W/apple II -4050-	Lkb Instruments, Inc.	JJQ	Class I	1984-02-10
K834448	Urinary Drainage Container	Vital Metrics, Inc.	KNX	Class II	1984-02-10
K834372	Pha-1 Programmable Hematology Analyz	Diagnostic Technology, Inc.	GKL	Class II	1984-02-10
K834345	Im-Check	Diagnostic Technology, Inc.	KTN	Class II	1984-02-10
K834337	Urihesive System - Improved	Convatec, A Division of E.R. Squibb & Sons	KNX	Class II	1984-02-10
K834247	Material Toothsade Resin	Scientific Pharmaceuticals, Inc.	EBF	Class II	1984-02-10
K834193	Jakobi Surg. Instruments #2 70/71	Imm Enterprises, Ltd.	FRG	Class II	1984-02-10
K834148	Philly Bolts	Philadelphia Medical Specialties	GWN	Class II	1984-02-10
K834040	Minature Pressure Transducer	Carbomedics, Inc.	DXO	Class II	1984-02-10
K833952	Fixation Pins	Ethicon, Inc	HTY	Class II	1984-02-10
K833899	Tdk ECG Electrode Mel-08	Tdk Corp.	DRX	Class II	1984-02-10
K833815	Zact Dental Arch Toothbrusch	Jfc International, Inc.	EFW	Class I	1984-02-10
K833792	Trantecsilicone Quartz Disp. Transd	American Bentley	DRS	Class II	1984-02-10
K833762	Percutaneous Retrograde Nephrostomy	Vpi	LJE	Unclassified	1984-02-10
K833728	Cardiac Wall Motion Device	Intl. Medical, Inc.	DSB	Class II	1984-02-10
K833646	Pulsatron Nerve Locator/stimulator	Edward Weck, Inc.	ETN	Class II	1984-02-10