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 2026-10-26, 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 2716 of 3530

510(k) clearances, page 2716 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880918	Captia Toxo-G	Mercia Diagnostics, Ltd.	LGD	Class II	1988-08-01
K880816	Model 130Yz CO2-Yag Surgical Laser System	Niic U.S.A., Inc.	GEX	Class II	1988-08-01
K880042	Acutron	Davis Assoc.	GZJ	Class II	1988-08-01
K882814	Neolens Prescription Spectacle Lens	Neolens, Inc.	HQG	Class I	1988-07-29
K882813	Neolens Sunglasses	Neolens, Inc.	HQY	Class I	1988-07-29
K882574	Boldrey Peripheral Retinal Lens	Ocular Instruments, Inc.	LQJ	Class II	1988-07-29
K882240	Storz Univ Irrigat/aspira & Phacoemulsifcation Pac	Storz Instrument Co.	GDM	Class I	1988-07-29
K882230	A Port Implant Vascular Access System - Detached	Therex Corp.	LJT	Class II	1988-07-29
K881977	Pressure Infusor	Primrose Medical, Inc.	KZD	Class I	1988-07-29
K881975	Set, Intravascular	Primrose Medical, Inc.	FPA	Class II	1988-07-29
K881817	Abuscreen(r) Ontrak(tm) for Amphetamines	Roche Diagnostic Systems, Inc.	DJP	Class II	1988-07-29
K881815	Abuscreen(r) Ontrak(tm) for Cocaine	Roche Diagnostic Systems, Inc.	DIO	Class II	1988-07-29
K881814	Abuscreen(r) Ontrak(tm) for Thc	Roche Diagnostic Systems, Inc.	LDJ	Class II	1988-07-29
K881217	Gent-L-Kare Sterile Urinary Leg Bag	Geneva Laboratories, Inc.	KNX	Class II	1988-07-29
K883014	Modified Intended Use of Monoject Bone Marrow Need	Sherwood Medical Co.	GAA	Class I	1988-07-28
K882917	Hi-Lo Table, Model 820-05	Tri W-G, Inc.	JFB	Class II	1988-07-28
K882916	Motorized Parallel Bar, Model 110	Tri W-G, Inc.	BXB	Class I	1988-07-28
K882903	Yesng Super Frecator	Ferguson Medical	GEI	Class II	1988-07-28
K882881	Sakura-Medscand Sca-1800 Automatic Coverslipper	Sakura Finetek USA Inc	KES	Class I	1988-07-28
K882874	Zinc Formalin	Anatech, Ltd.	LDX	Class I	1988-07-28
K882873	Fieldtex Hematoxylin	Anatech, Ltd.	KQC	Class I	1988-07-28
K882866	Earle's Balanced Salt Solution (Ebss) No. 210-3000	J R Scientific	KIT	Class I	1988-07-28
K882865	Dulbecco's Phosphate Buffered Saline No. 210-3025	J R Scientific	KIT	Class I	1988-07-28
K882864	Hanks' Balanced Salt Solution (Hbss) No. 210-3011	J R Scientific	KIT	Class I	1988-07-28
K882862	Dulbecco's Phosphate Buffered Saline No. 200-2530	J R Scientific	KIT	Class I	1988-07-28
K882859	Dulbecco's Phosphate Buffered Saline No. 210-3020	J R Scientific	KIT	Class I	1988-07-28
K882858	Nutrient Mixture F-12 (Ham), No. 210-3551	J R Scientific	KIT	Class I	1988-07-28
K882857	Hanks' Balanced Salts No. 210-3010	J R Scientific	KIT	Class I	1988-07-28
K882856	Earle's Balanced Salt Solution No. 210-3005	J R Scientific	KIT	Class I	1988-07-28
K882855	Hanks' Balanced Salt Solution No. 210-3015	J R Scientific	KIT	Class I	1988-07-28
K882852	Dulbecco's Phosphate Buffered Saline, No 200-2525	J R Scientific	KIT	Class I	1988-07-28
K882845	Earle's Balanced Salts No. 200-2500	J R Scientific	KIT	Class I	1988-07-28
K882844	Hank's Balanced Salts No. 200-2510	J R Scientific	KIT	Class I	1988-07-28
K882843	Hank's Balanced Salts No. 200-2515	J R Scientific	KIT	Class I	1988-07-28
K882842	Earle's Balanced Salts (Ebss) No. 200-2505	J R Scientific	KIT	Class I	1988-07-28
K882841	Hank's Balanced Salts (Hbss) No. 200-2521	J R Scientific	KIT	Class I	1988-07-28
K882840	Hank's Balanced Salts (Hbss) No. 200-2520	J R Scientific	KIT	Class I	1988-07-28
K882839	Earle's Balanced Salts (Ebss) No. 200-2506	J R Scientific	KIT	Class I	1988-07-28
K882838	Minimum Essential Medium Eagle, No. 200-2180	J R Scientific	KIT	Class I	1988-07-28
K882796	Slip-Coat(tm) Catheters	Cook Inc.	DQO	Class II	1988-07-28
K882673	Sigma 1 Wobbler Biopsy Kit	Kontron Instruments, Inc.	FCH	Class I	1988-07-28
K882617	Brevet Cassette Sterilization Module	Brevet Inc.	FSM	Class I	1988-07-28
K882450	Gem-Stat W/comp. Gem-Statpak/gem-Check & Crit Chk.	Diamond Sensor Systems	JJE	Class I	1988-07-28
K882416	Clearblue Easy	Unipath, Ltd.	LCX	Class II	1988-07-28
K882198	Minimon 7132B Patient Monitor	Kontron Instruments, Inc.	DPS	Class II	1988-07-28
K882188	Model 404 Adult Heart Rate/blood Pressure Monitor	Ivy Biomedical Systems, Inc.	DXN	Class II	1988-07-28
K882097	Tunneling Stylet	Quinton, Inc.	DRB	Class II	1988-07-28
K882093	Cardiocap(tm) Cmo-104 Monitor	Datex Division Instrumentarium Corp.	DSK	Class II	1988-07-28
K882086	Qtest(tm) Pregnancy	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1988-07-28
K882085	Propaq 104(Tm)	Protocol Systems, Inc.	DSK	Class II	1988-07-28