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 3321 of 3528

510(k) clearances, page 3321 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802884	Corning Normal Glycosylated Hemoglobin	Corning Medical & Scientific	JBD	Class II	1980-12-22
K802794	Pro-Ophta Sticks	Secol Co.	HOZ	Class II	1980-12-22
K802644	Emerg. Oxygen Kit #65350 & #65399 Case	B & F Medical Products, Inc.	CAN	Class I	1980-12-22
K802593	Keratoplasty Suturing Lens	Paris Contact Lens Laboratory	HPX	Unclassified	1980-12-22
K802389	Gambro Lundia Plate Disp. Dialyzer	Gambro, Inc.	FJG	Class II	1980-12-22
K802353	Micro Thin-Pii, #0523	Cardiac Pacemakers, Inc.	DXY	Class III	1980-12-22
K802352	Micro Thin-Dii, #0521	Cardiac Pacemakers, Inc.	DXY	Class III	1980-12-22
K802332	Intraject	General Medical Engineering Corp.	KYG	Class I	1980-12-22
K802230	Bellco Single Needle Double Head Pump	Cardio Med Supplies, Inc.	FIF	Class II	1980-12-22
K802168	Drager Av2 Anesthesia Ventilator	Draeger, Inc.	CBK	Class II	1980-12-20
K802982	Gauze, Absorbable X-Ray Detect. Lap Spg.	Stanford Laboratories	GDY	Class I	1980-12-19
K802980	Disposable Sterile Lap Sponge	Anago, Inc.	KKX	Class II	1980-12-19
K802977	Ipocarbon Stretch Stockinette	Ipos Luneburg			1980-12-19
K802976	Carbonacryl	Ipos Luneburg			1980-12-19
K802974	Rapi-Dot	Organon LLC	JHJ	Class II	1980-12-19
K802973	Ispvac Tm	Innovative Surgical Products, Inc.	GCY	Class I	1980-12-19
K802963	101, 151, 161 Portable Audiometers	Amplaid USA, Inc.	EWO	Class II	1980-12-19
K802959	Nikon Urine Refractomer Sg-1	Nippon Kogaku, Inc.	JRE	Class I	1980-12-19
K802955	Monitor, Airway Pressure	Novametrix Medical Systems, Inc.	CAP	Class II	1980-12-19
K802945	Pressure Monitoring Set	Norton Performance Plastics Corp.	DQO	Class II	1980-12-19
K802926	Sci-Pharm Universal Cavity Varnish	Scientific Pharmaceuticals, Inc.	LBH	Class II	1980-12-19
K802925	6-415 Filter, Element, 170-C	Lifecare Services, Inc.	DSK	Class II	1980-12-19
K802923	Beckman Astra Systems Calcium Chemistry	Beckman Instruments, Inc.	CIC	Class II	1980-12-19
K802916	Montg. Tracheal Cannula	Boston Medical Products, Inc.	BTO	Class II	1980-12-19
K802915	Montg. Tracheal Trephine Fene Strator	Boston Medical Products, Inc.	KBF	Class I	1980-12-19
K802914	6-435 Filter Pad, 5/Pkg.	Lifecare Services, Inc.	CAH	Class II	1980-12-19
K802902	Cybrex Carbamazepine	Abbott Medical	KLT	Class II	1980-12-19
K802899	Ceramibond	Zulauf, Inc.	DYW	Class II	1980-12-19
K802891	Argyle Double Seal Chest Drainage Unit	Sherwood Medical Co.	CCJ	Class II	1980-12-19
K802883	T3-Squibb Ria Kit	E. R. Squibb & Sons, Inc.	CDP	Class II	1980-12-19
K802881	Absele* Absorbable Bone Sealant	Ethicon, Inc			1980-12-19
K802879	Buckberg-Shiley Blood Cardioplegic Spl.	Shiley, Inc.	DTR	Class II	1980-12-19
K802877	Amikacin Ria Kit	Antibodies, Inc.	KLQ	Class II	1980-12-19
K802873	Shea Locking Bail Prosthesis	Richard'S Medical Equip., Inc.	ETB	Class II	1980-12-19
K802868	Accu-Counter Surgical Sponge Counting Sy	Surgical Systems, Inc.			1980-12-19
K802865	Safe T Count	Instranetics, Inc.	KDC	Class I	1980-12-18
K802853	Cleanser, Root Canal	Dentsply Intl.	KJJ	Unclassified	1980-12-18
K802842	Single Vial Lipase Test Kit	Biodynamics Corp.	CHI	Class I	1980-12-18
K802841	Digoxin Radioimmunoassay Kit	American Diagnostic Corp.	DNL	Class II	1980-12-18
K802831	Gambro Peritoneal Dialysis Monitor	Gambro, Inc.	KPF	Class II	1980-12-18
K802793	Lomatuell Ointment Dressing	Secol Co.	NAE	Class I	1980-12-18
K802739	Urine Collection Bag Type 710Ap	Bio D Corp.	KNX	Class II	1980-12-18
K802738	Urine Collection Bag Type 1505V	Bio D Corp.	KNX	Class II	1980-12-18
K802737	Urine Collection Bag Type 1590V	Bio D Corp.	KNX	Class II	1980-12-18
K802736	Urine Coolection Bag Type 2090V	Bio D Corp.	KNX	Class II	1980-12-18
K802735	Urine Collection Bag Type 740Ap	Bio D Corp.	KNX	Class II	1980-12-18
K802734	Urine Collection Bag Type 710	Bio D Corp.	KNX	Class II	1980-12-18
K802733	Urine Collection Bag Type Ap2090v	Bio D Corp.	KNX	Class II	1980-12-18
K802732	Urine Collection Bag Type Ap2132v	Bio D Corp.	KNX	Class II	1980-12-18
K802729	Urine Collection Bag Type 2132V	Bio D Corp.	KNX	Class II	1980-12-18