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 3061 of 3528

510(k) clearances, page 3061 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K842058	Hemodialysis Bath Concentrate Solution	Pharmaceutical Development Systems	FKQ	Class II	1984-07-26
K842033	Electrode Placement Arm Part Garment	Bio-Stimu Trend Corp.	GXY	Class II	1984-07-26
K841945	Enteral Feeding Bottle	Superior Plastic Products Corp.	KNT	Class II	1984-07-26
K841879	Lft - 212	Medical Monitoring Systems, Inc.	LIL	Unclassified	1984-07-26
K841872	Uncuffed Reinforced Tracheal Tube	Mallinckrodt Critical Care	BTR	Class II	1984-07-26
K841789	Sechrist Air-Oxygen Mixer & Ancillary	Shiley, Inc.	BZR	Class II	1984-07-26
K841773	Infant Nasal Cannulae Assembly	Ackrad Laboratories	BZD	Class II	1984-07-26
K841720	E-Z-Em Percutaneous Nephrostomy Sets	E-Z-EM, Inc	LJE	Unclassified	1984-07-26
K841350	Salivary Bypass Tube	E. Benson Hood Laboratories, Inc.			1984-07-26
K842920	Safranin, 1% W/v	E K Ind., Inc.			1984-07-25
K842719	Standard Wheelchair	Greene International Corp.	IQC	Class II	1984-07-25
K842643	Massaped	Heddernheimer Metallwarenfabrik GmbH	ILJ	Class II	1984-07-25
K842642	Balsan 700	Heddernheimer Metallwarenfabrik GmbH	ILJ	Class II	1984-07-25
K842641	Hydro/bubble Bath Device 300	Heddernheimer Metallwarenfabrik GmbH	ILJ	Class II	1984-07-25
K842635	Sheridan/endo-Pak	Sheridan Catheter Corp.	BTR	Class II	1984-07-25
K842441	Axiom Stable II Cholesterol Test	Axiom, Inc.	CHH	Class I	1984-07-25
K842390	Syva Iq 190 Digital Pipetter Diluter	Syva Co.	JQW	Class I	1984-07-25
K842311	Chemistry Analyzer, Gen. Purpose	Hml Inc/Biotechnology Transfer	JJQ	Class I	1984-07-25
K842289	Sr- Model 230	Hirata Sangyo Co. USA, Inc.	FRN	Class II	1984-07-25
K842263	Mtp E.v. Infusion Pump	Ziehm International, Inc.	FRN	Class II	1984-07-25
K842238	Clinitek 10 Semi-Auto Urinalysis Sys	Miles Laboratories, Inc.	KQO	Class I	1984-07-25
K842210	Ivent 302Vc Dual Controller	Ivent Corp.	LDR	Class II	1984-07-25
K840339	Umbilical Vessel Catheter	Catheter Technology Corp.	FOS	Class II	1984-07-25
K842756	Butterfly II Pn Infusion Needle	Cosmetic Sciences, Inc.	FMI	Class II	1984-07-23
K842608	Infant Percussor Pa-010	Alpha Medical Systems	BYI	Class II	1984-07-23
K842591	Ultrasound Probe Covers-Sterile	Applied Medical Devices, Inc.	IYO	Class II	1984-07-23
K842227	Aimed Disposable Syringe, Various Sizes	Tech-Cons Ltd., Intl.	FMF	Class II	1984-07-23
K842149	Pms Suture Pack/tray;vertex Suture	Professional Medical Services			1984-07-23
K842091	Dispos. Acu-Cut Soft Tissue Biopsy	The Healthcare Group Laboratories, Inc.			1984-07-23
K842030	Neutral Pos-Chair Surgeon Chair	Neutral Pos-Chair Co.	FZK	Class I	1984-07-23
K841901	Oxymizer Flow Restrictor	Chad Therapeutics, Inc.	BYX	Class I	1984-07-23
K841900	First Response Emerg. Eye Injuries	Reed Products, Inc.	LRR	Not classified	1984-07-23
K841899	First Response Emerg. Medical Sys Bones	Reed Products, Inc.	KGX	Class I	1984-07-23
K841897	First Response Emerg. Medical System	Reed Products, Inc.	KGX	Class I	1984-07-23
K841741	Single Hair Transplant Graft	Paris Products, Inc.	FZT	Class I	1984-07-23
K841717	Intravenous Injection Set	Philadelphia Biologics Center	FPA	Class II	1984-07-23
K841628	Wire	Plastafil, Inc.	HXN	Class I	1984-07-23
K841562	Hesung Blood Transfusion Sets	Amkor Trading Co.	FPA	Class II	1984-07-23
K841349	Esophageal Tube	E. Benson Hood Laboratories, Inc.	KNT	Class II	1984-07-23
K840874	Rody Breast Pump	Kean-Rody Manufacturer	HGY	Class I	1984-07-23
K840387	Surg-a-Stat Loop Tip 2	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-07-23
K840377	Surg-a-Stat Cardiovascular Tip	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-07-23
K840375	Surg-a-Stat Loop Tip 15	Suncoast Medical Manufacturers, Inc.	GEI	Class II	1984-07-23
K840370	Surg-a-Stat Vasectomy Tip	Suncoast Medical Manufacturers, Inc.	GET	Class I	1984-07-23
K831632	Medical Rubber Gloves-Sterile-Surgeons	Tagum Rubber Industries, Ltd.	KGO	Class I	1984-07-23
K842672	Minimum Essential Med. M0769 W/wo	Sigma Chemical Co.	KIT	Class I	1984-07-20
K842671	Basal Med. Eagle B8265, W/earls Salts	Sigma Chemical Co.	KIT	Class I	1984-07-20
K842613	Compact Visual	Nicolet Biomedical Instruments	IKN	Class II	1984-07-20
K842612	Compact Auditory	Nicolet Biomedical Instruments	IKN	Class II	1984-07-20
K842611	Ca2000	Nicolet Biomedical Instruments	IKN	Class II	1984-07-20