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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3433 of 3526

510(k) clearances, page 3433 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781436	Delta Test Assay, Hdl Chloresterol	BD Becton Dickinson Vacutainer Systems Preanalytic			1978-10-03
K781432	Stat Ultra Violet Liquid	Beckman Instruments, Inc.	JHS	Class II	1978-10-03
K781420	Specialty Sponges	Ipco Corp.	EFQ	Unclassified	1978-10-03
K781369	Microdilution Anaerobe Id. Panel	Cnr Labs	JSF	Class I	1978-10-03
K781368	Microdilution Gram-Negative Id. Panel	Cnr Labs	JSS	Class I	1978-10-03
K781367	Microdilution Strep Id. Panel	Cnr Labs	JSS	Class I	1978-10-03
K781348	Fociscan Echovisor System	Metrix Teknika, Inc.			1978-10-03
K781319	Therapy Appar. 422 Interferential	General Theraphysical, Inc.	IPF	Class II	1978-10-03
K781318	Dynatron 406 Electrotherapy Apparatus	General Theraphysical, Inc.	IPF	Class II	1978-10-03
K781317	Ultrasonic Therapy Apparatus, 407	General Theraphysical, Inc.	IMI	Class II	1978-10-03
K781315	Muscle Stimulation Apparatus	General Theraphysical, Inc.	IPF	Class II	1978-10-03
K781314	Therapy Unit & Electrodiag.	General Theraphysical, Inc.	GXY	Class II	1978-10-03
K781252	Generator, Pulse, Model 5997	Medtronic, Inc.	DXY	Class III	1978-10-03
K781208	Generators, Pulse, Models 5988/5989	Medtronic, Inc.	DXY	Class III	1978-10-03
K781048	Thc Direct Ria Kit	Immunalysis Corporation	LAT	Class II	1978-10-03
K780991	Parallel Blade Marker	Nestor Engineering Associates, Inc.	EMF	Class I	1978-10-03
K780990	Stainless Steel Template	Nestor Engineering Associates, Inc.			1978-10-03
K780989	Devin-Nestor Square Knife	Nestor Engineering Associates, Inc.	EMF	Class I	1978-10-03
K780988	Devin-Nestor Pneumatic Tourniquet	Nestor Engineering Associates, Inc.	KCY	Class I	1978-10-03
K780776	Arcobiolith Pacemaker Model	Arco Medical Products Co.	DXY	Class III	1978-10-03
K781515	Model Ls-80 Adult Ventilation Monitor	Bourns Medical Systems, Inc.	BZQ	Class II	1978-10-02
K781303	Bio-Pro Unit	BD Becton Dickinson Vacutainer Systems Preanalytic	FKR	Class II	1978-10-02
K780478	Liquid Crystal Thermographic System	Thermal Imagery, Inc.			1978-10-02
K781098	Brush, Applicator	3M Company	KXR	Class I	1978-09-29
K780987	Soft Silicone Elastomer Sponge Explant	Medical Instrument Research Assoc., Inc.	HOZ	Class II	1978-09-28
K781608	Central Peg Tibial Component	Howmedica Corp.	HRY	Class II	1978-09-27
K781597	Pm 2000 Automatic Patient Chair	Time Motion System Co.	FFG	Class II	1978-09-27
K781596	Hearing Aid, Model 775 Pp/agc	Danavox, Inc.	ESD	Class I	1978-09-27
K781595	Body-Worn Hearing Aid, Model 787Pp	Danavox, Inc.	ESD	Class I	1978-09-27
K781577	Disposable Cardiotomy; H-700F, H-700	C.R. Bard Inc	DTN	Class II	1978-09-27
K781574	Plasti-Pore Septal Button	Richard'S Medical Equip., Inc.	FZE	Class II	1978-09-27
K781528	Coulter Electrolyte Analyzer System	Coulter Electronics, Inc.	JJE	Class I	1978-09-27
K781516	Test System Tissue Cell Culture Slide	Zeus Scientific LLC	KIY	Class I	1978-09-27
K781503	Technicon Stat/lyte Ise Electrolyte	Technicon Instruments Corp.	JJC	Class I	1978-09-27
K781491	Pro-Mold, Custom Ear	Mcghan Medical Corp.	EWD	Unclassified	1978-09-27
K781488	Mvs-Model Seu-6, Deu-6	Dentsply Intl.	EHZ	Class I	1978-09-27
K781486	Steri-Vac Power Units	Cpac, Inc.	EHZ	Class I	1978-09-27
K781483	Ortho*t-4 Ria (Peg) Kit	Ortho Diagnostics, Inc.	CDX	Class II	1978-09-27
K781482	Ortho*t-3 Uptake Kit	Ortho Diagnostics, Inc.	KHQ	Class II	1978-09-27
K781481	Ortho*t-3 Ria (Peg) Kit	Ortho Diagnostics, Inc.	CDP	Class II	1978-09-27
K781472	Mitrophenyl, Alkaline Phosphates	Beckman Instruments, Inc.	CJE	Class II	1978-09-27
K781451	Flat Wrench	Orthopedic Equipment Co., Inc.	HXS	Class I	1978-09-27
K781450	Drivers	Orthopedic Equipment Co., Inc.	GFC	Class I	1978-09-27
K781449	Harrington Spinal Elevator	Orthopedic Equipment Co., Inc.	GEG	Class I	1978-09-27
K781448	Harrington Hook Clamp	Orthopedic Equipment Co., Inc.	GEN	Class I	1978-09-27
K781447	Threaded Rod Clamp	Orthopedic Equipment Co., Inc.	GEN	Class I	1978-09-27
K781446	C Ring Clincher	Orthopedic Equipment Co., Inc.	GEN	Class I	1978-09-27
K781444	Outrigger Distraction Unit	Orthopedic Equipment Co., Inc.	KWP	Class II	1978-09-27
K781443	Harrington Spine Instrumentation	Orthopedic Equipment Co., Inc.	KWP	Class II	1978-09-27
K781427	Ms-2 Bacterial Id. System	Abbott Medical	JSS	Class I	1978-09-27