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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2378 of 3531

510(k) clearances, page 2378 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921806	Vacutainer(r) Brand Sst(r) and Cat Tubes	BD Becton Dickinson Vacutainer Systems Preanalytic	JKA	Class II	1992-04-29
K921768	Hazel II	KCI USA, Inc.	IOQ	Class II	1992-04-29
K921636	Vacutainer(r) Brand Safety-Lok Blood Collect Set	BD Becton Dickinson Vacutainer Systems Preanalytic	GIM	Class II	1992-04-29
K921467	Drake & Drake/200 Dl	Am Scooters	INI	Class II	1992-04-29
K921455	Aca Lactate Dehydrogenase Isoenzyme 1 (Ld1) Method	E.I. Dupont de Nemours & Co., Inc.	CFE	Class II	1992-04-29
K921210	Surgical Instrument Stand	Murphy Medical Center	MDM	Class I	1992-04-29
K921206	Hcg Control	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	JJX	Class I	1992-04-29
K921095	Pacer Disposable Yankauer Suction Instrument	Pacer Tool & Plastics, Inc.	GBX	Class I	1992-04-29
K921089	Lyphochek(r) Fructosamine Control	Bio-Rad	JJX	Class I	1992-04-29
K921069	Fortress 1800Fs Rear Wheel Drive Scooter	Fortress Scientific, Ltd.	INI	Class II	1992-04-29
K921005	Autoloader	Innovative Medical Systems, Inc.	JQW	Class I	1992-04-29
K920934	Halocath Laser Catheters	Trimedyne, Inc.	GEX	Class II	1992-04-29
K920759	Critspin Micro-Hematocrit	Stat-Spin Technologies	GKG	Class II	1992-04-29
K920642	Micro-Coll Collagen Dermal Wound Spray	Micro-Collagen Pharmaceutics, Ltd.	MGQ	Unclassified	1992-04-29
K920589	Angled Delivery Device	Laserscope	GEX	Class II	1992-04-29
K920544	Sysmex Hematology System Accessories	Toa Medical Electronics USA, Inc.	GKZ	Class II	1992-04-29
K920485	Pupldent Etch N Prep	Pulpdent Corporation	EBF	Class II	1992-04-29
K920483	10% Phosphoric Acid Etching Gel	Pulpdent Corporation	EBF	Class II	1992-04-29
K920422	B-D Interlink Syringe Cannula	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1992-04-29
K920402	Roche Cobas Mira Plus	Roche Diagnostic Systems, Inc.	JJE	Class I	1992-04-29
K920378	Pace 2 System for Chlamydia Trachomatis	Hologic, Inc.	LSK	Class I	1992-04-29
K920179	Zippie P500	Sunrise Medical Quickie Designs, Inc.	IOR	Class I	1992-04-29
K915729	Auqasoothe/aqua Med	Aquasoothe	ISA	Class I	1992-04-29
K915675	Electrode, Ion Specific	Alko Diagnostic Corp.	JFP	Class II	1992-04-29
K915502	Medline, Gore-Tex Barrier, Surgical Gowns & Drapes	Medline	FYA	Class II	1992-04-29
K915175	Reddick Retractor	Ideal Medical, Inc.	GAD	Class I	1992-04-29
K914804	Radius Osteotomy Plates	Link America, Inc.	HRS	Class II	1992-04-29
K914362	Top Cervical Spine Plates & Titanium Bone Screws	Acorn Group, Inc.	KWQ	Class II	1992-04-29
K913731	Enzygnost(r) Toxoplasmosis/igg	Behring Diagnostics, Inc.	LGD	Class II	1992-04-29
K913117	Zb-860Pa Multiparameter Transmitter	Nihon Kohden America Inc	DSI	Class II	1992-04-29
K921830	Rionet Hearing Aid Hb-52T	Authorized Hearing Systems, Inc.	ESD	Class I	1992-04-28
K921406	Silicont Bur Block	Innovators, Inc.	EJL	Class I	1992-04-28
K920894	Decompression Tubes	Applied Medical Technologies	KNT	Class II	1992-04-28
K920758	Jenker Needle Stick Protector	Dentsply Intl.	DZM	Class I	1992-04-28
K920682	Phoenix Steri-Tech Sterile Dental Pack Gen-10001	Phoenix Steri-Tech, Inc.	FXX	Class II	1992-04-28
K920598	True/flex Humerus Cap	Applied Osteo Systems, Inc.	HSB	Class II	1992-04-28
K920484	2.5% Nitric Acid Etching Gel	Pulpdent Corporation	EBF	Class II	1992-04-28
K920482	14% Hydrofluoric Acid Etching Gel	Pulpdent Corporation	EBF	Class II	1992-04-28
K920460	4% Acidulated Phosphate Fluoride Etching Gel	Pulpdent Corporation	ELL	Class II	1992-04-28
K920377	Mortara Instrument Model ECG Prevu	Mortara Instrument, Inc.	LOS		1992-04-28
K920189	Gx-C Cephalometer	Gendex Corp.	EAG	Class II	1992-04-28
K920103	Episcope, Model 47300	Welch Allyn Inc	KZF	Class I	1992-04-28
K920095	Mrt-50 Multiview Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-04-28
K915358	Promeon Hydrogel Dressing #45 Nonsterile W/ Mesh	Medtronic, Inc.	KGX	Class I	1992-04-28
K914904	Therapeutic Stimulator 2100 (Ts-2100)	Myo/Kinetic Systems, Inc.	IPF	Class II	1992-04-28
K914803	Schwabe Radius Plates	Link America, Inc.	HRS	Class II	1992-04-28
K914624	Ph Meter, Modification	Synectics-Dantec	FFT	Class I	1992-04-28
K914367	Electrosurgical Generator Model Esu100/250/550	Gyne-Tech Instrument Corp.	HGI	Class II	1992-04-28
K914178	Corrected-V.p.s.	Jeneric/Pentron, Inc.	ELW	Class II	1992-04-28
K913910	Enzygnost(r) Anti-Cmv Igg	Behring Diagnostics, Inc.	LFZ	Class II	1992-04-28