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 2288 of 3531

510(k) clearances, page 2288 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931200	Battery Packs (Various Models)	Access / God Loves You	IZL	Class II	1993-07-13
K930925	Intrex Interoral Dental X-Ray Unit	Keystone X-Ray, Inc.	EAP	Class II	1993-07-13
K930885	Pneumatic Compression Device	Bt Medical Co., Inc.	JAA	Class II	1993-07-13
K930357	Accessory to Universal Octopaque	Octostop, Inc.	KXH	Class I	1993-07-13
K930273	Alpha	Raymax Medical Corp.	IZZ	Class II	1993-07-13
K930260	Acoustic Analyzer Aa30	Precision Acoustics Ind., Inc.	EWO	Class II	1993-07-13
K926508	Intrasite Gel	Smith & Nephew United, Inc.	NAE	Class I	1993-07-13
K926217	Terumo Angiographic Catheter for Laporoscopic Use	Terumo Medical Corp.	GBZ	Class I	1993-07-13
K925789	Debusk Temp. Syst. Esophageal Stethoscope	DeRoyal Industries, Inc.	BZT	Class II	1993-07-13
K925571	Oti European Compression System	Osteo-Technology Intl., Inc.	HRS	Class II	1993-07-13
K925548	Fibracol Collagen-Alginate Dressing	Johnson & Johnson MEDICAL GmbH	FMF	Class II	1993-07-13
K925030	Surgeon's Glove	Wuhrlin Soplamed (M) Sdn Bhd	KGO	Class I	1993-07-13
K924386	Patient Examination Gloves	Wuhrlin Soplamed (M) Sdn Bhd	LYY	Class I	1993-07-13
K924213	Eclipse 2100(Tm), Modification	Elipse Surgical Technologies, Inc.	GEX	Class II	1993-07-13
K924118	Propak	Dental Services, Inc.	KCT	Class II	1993-07-13
K923840	Needle-Grabber	Guardian Angel Products, Inc.	GDF	Class I	1993-07-13
K923323	Intermittent Injection Site	Kawasumi Laboratories Co., Ltd.	FOZ	Class II	1993-07-13
K923183	Genesis Spray Tip Atomizer	Mai	FMF	Class II	1993-07-13
K923104	Tropic-Air	Seabrook Medical Systems, Inc.	DWJ	Class II	1993-07-13
K923096	Uresil Billiary Catheter	Uresil, LLC	FGE	Class II	1993-07-13
K922886	Various Models of Sunglasses	Hard Rock Cafe, Inc.	HQY	Class I	1993-07-13
K922869	Total Condylat Type Knee System	Osteo Technology, Inc.	JWH	Class II	1993-07-13
K922816	U P Custom Design, Inc. Cot Equipment Carrier	Up Custom Design, Inc.	FPP	Class I	1993-07-13
K922204	Mill-Rose Pulmonary Forceps	Mill-Rose Laboratory	EOQ	Class II	1993-07-13
K921853	4 Sure Tm Feeding Tubes	Boston Pacific Medical, Inc.	KNT	Class II	1993-07-13
K915529	Fpc/sfpc/rfpc Acetabular Component	Implantology Corp.	JDL	Class III	1993-07-13
K930847	Argyle Turkel Safety Thoracentesis Proc. Tray	Sherwood Medical Co.	FMF	Class II	1993-07-12
K925453	Sherwood Medical Arterial Blood Gas Kit I	Sherwood Medical Co.	CBT	Class I	1993-07-12
K932219	Suture Set or Laceration Trays (Packs)	Associated Medical Products Co.	KDD	Class I	1993-07-09
K932160	Systemate Creatinine Test Item Number 65413	Em Diagnostic Systems, Inc.	CGX	Class II	1993-07-09
K930787	Laparoscopic Cholangiography Catheter Kit	Advanced Surgical, Inc.	DQX	Class II	1993-07-09
K930700	Medlines Repeat Performance Surgical Pack System	MEDLINE INDUSTRIES, LP - Northfield	LRO	Class II	1993-07-09
K930608	Onik-Cohen Access Set	Cook Incorporated	KOD	Class II	1993-07-09
K930301	Trocar Sheath Anchor	Origin Medsystems, Inc.	GCJ	Class II	1993-07-09
K926566	Care-E-Vac	Aeros Instruments, Inc.	BTA	Class II	1993-07-09
K925970	Model 3D3 Osmometer	Advanced Instruments, LLC	JJM	Class I	1993-07-09
K925815	Reusable Liquidproof Bootie	Amsco Sterile Recoveries, Inc.	FXP	Class I	1993-07-09
K925628	Ultratuff Cut Resistant Glove Liner	Baxter Healthcare Corporation	LYU	Class I	1993-07-09
K924588	Zeiss Laser Indirect Ophthalmoscope	Carl Zeiss, Inc.	GEX	Class II	1993-07-09
K924541	Epidural Minipack	Concord/Portex	BYO	Class I	1993-07-09
K924468	Sterile Instrument Trays/basin Sets	Baxter Healthcare Corporation	LRO	Class II	1993-07-09
K924011	Origin Blunt Tip Surgical Trocar	Origin Medsystems, Inc.	GCJ	Class II	1993-07-09
K923835	The Eleventh Finger	Guardian Angel Products, Inc.	GDF	Class I	1993-07-09
K923231	Cardio-Pak Basic Pump Pack	Cardio-Med-Associates, Inc.	DWE	Class II	1993-07-09
K922766	Acufex Biofix Absorbable Fixation Rod-Modification	Acufex Microsurgical, Inc.	HTY	Class II	1993-07-09
K921322	Morse Anesthesia Manifold	Namic	FPA	Class II	1993-07-09
K921158	O.r./surgeons Gown, Item No. 4950	The Sewing Source, Inc.	FYA	Class II	1993-07-09
K921157	O.r./surgeons Gown, Item No. 4942	The Sewing Source, Inc.	FYA	Class II	1993-07-09
K921156	O.r./surgeons Gown, Item No.4941	The Sewing Source, Inc.	FYA	Class II	1993-07-09
K921155	O.r./surgeons Gown, Item No. 4962	The Sewing Source, Inc.	FYA	Class II	1993-07-09