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 2026-11-02, 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 2511 of 3531

510(k) clearances, page 2511 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902872	Nonabsorbable Polypropylene Surgical Suture*	United States Surgical, A Division of Tyco Healthc	GAW	Class II	1990-09-27
K902860	Intelect 170	Chattanooga Group, Inc.	IMG	Class II	1990-09-27
K902856	Bard Filtered Cardiotomy Reservoir	C.R. Bard Inc	DTP	Class II	1990-09-27
K902779	Modification Type 9266 Sa02 System Athena	S & W Medico Teknik	DQA	Class II	1990-09-27
K902606	Radiopaque Ruler	Professional Medical Services	KPR	Class II	1990-09-27
K902583	Joint Moton Imager(tm)	Concord Imaging, Ltd.	JAA	Class II	1990-09-27
K902429	Modified Heartstart Defibrillation Electrode	Laerdal Mfg. Corp.	LDD	Class II	1990-09-27
K902394	Resubmitted Multiorgan Perfusion Cannula	Fresenius USA, Inc.	DWF	Class II	1990-09-27
K901899	Roadrunner Wire Guide	Cook Inc.	DQX	Class II	1990-09-27
K901885	Partner Volume Monitor	Bird Products Corp.	BZK	Class II	1990-09-27
K903906	Percutaneous Catheter Introducer Kit	Intec Medical, Inc.	DYB	Class II	1990-09-26
K903707	Deflecting Wire Grasper	Cook, Inc.	HCZ	Class II	1990-09-26
K903426	Insulin Syringe Guide	Bay State Anesthesia, Inc.	FMF	Class II	1990-09-26
K903390	Medrad Mark V-Plus Injector	Medrad, Inc.	DXT	Class II	1990-09-26
K903351	Prolax Disposable Latex Gloves (Procedure Sterile)	Prolax Medical Products, Inc.	LYY	Class I	1990-09-26
K903285	Micro Bright Ventilation Tubes	Invotec International, Inc.	ETD	Class II	1990-09-26
K902975	Twin Balloon Injector	Zinnanti Surgical Instruments, Inc.	LKF	Class II	1990-09-26
K902965	Fdi 2000 Ultrasonic Skin Scanner	Fulmer Dyson Intl.	IYO	Class II	1990-09-26
K902881	Lab-Site Safety Needle	Simplivia Healthcare Ltd.	CBT	Class I	1990-09-26
K902682	Stick-Gard Sterile Cap	Integrated Medical Systems Inc	LDQ		1990-09-26
K902552	Gerber Precious Care Electric Breast Pump	Gerber Products Co.	HGY	Class I	1990-09-26
K902275	Percutaneous Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	1990-09-26
K902091	Schneider Monorail(tm) Softrac-Pta(tm) Catheter	Schneider Intl., Ltd.	LIT	Class II	1990-09-26
K902002	Models 5069/5071 Myocardial Pacing Leads	Medtronic, Inc.	DTB	Class III	1990-09-26
K904195	Disposable Face Mask	Bp, Ltd.	BYG	Class I	1990-09-25
K903829	Ast Reagent	Amresco, Inc.	CIT	Class II	1990-09-25
K903730	D.i.c. Tracheostomy Tubes & Laryngectomy Tubes	Concord/Portex	BTO	Class II	1990-09-25
K903404	Flocare F	Flocare Medical	BZO	Class I	1990-09-25
K903219	Abbott Testpack Plus Tm Hcg-Combo	Abbott Medical	JHI	Class II	1990-09-25
K903215	Labmaster Beta-2-Microglobulin Elisa Test Kit Tm	Bioproducts for Science, Inc.	JZG	Class II	1990-09-25
K903207	Auto Suture Endoscopic Suction/irrigatrion Device	United States Surgical, A Division of Tyco Healthc	HET	Class II	1990-09-25
K903144	Kodak Ektachem Clinical Chemistry Slides (Eco2)	Eastman Kodak Company	KHS	Class II	1990-09-25
K903130	London Diagnostics Lumatag(tm) Intact Pth Assay	London Diagnostics, Inc.	CEW	Class II	1990-09-25
K902811	Routine Dressing Tray	Orion Life Systems, Inc.	MCY	Class II	1990-09-25
K902678	Liquid Stable Cholesterol Reagent Kit	Trace Scientific, Ltd.	CHH	Class I	1990-09-25
K902534	Centauri Erbium Yittrium Aluminum Garnet Laser	Pfizer Laser Systems	GEX	Class II	1990-09-25
K902393	Coacute Antithrombin Chromogenic Assay	Kabi Diagnostica	JBQ	Class II	1990-09-25
K902057	Percor Stat Dl 8.5 Fr 40Cc Iab Only/labeling Chang	Datascope Corp.	DSP	Class II	1990-09-25
K900881	Or-340 Intraoperative Ultrasound System	Cerenovus, Inc.	IYO	Class II	1990-09-25
K904125	Uc Imu a	Eucardio Laboratory, Inc.	DER	Class II	1990-09-24
K904038	Myoglobin Ria Test Kit	Immuno Diagnostic Center, Inc.	DDR	Class II	1990-09-24
K904037	Pumuckl And/or Dieterle	Pumuckl	HQZ	Class I	1990-09-24
K903834	N. M. Beale Company Vu-Thru Water Bottle	N.M. Beale Co., Inc.	OCX	Class II	1990-09-24
K903826	Sarah Coventry Sunglasses	R. N. Koch, Inc.	HQY	Class I	1990-09-24
K903723	Barrier Free Ceiling Lift, Mdls Hrs-1/2F,1/4f,1/6f	Barrier Free Lifts, Inc.	FNG	Class II	1990-09-24
K903567	Bio* Nephross Andante, Moderato, Allegio h.f.	bioMerieux, Inc.	FJI	Class II	1990-09-24
K903566	Dade Immunoassay Controls, Levels I, II, III	Baxter Healthcare Corporation	JJY	Class I	1990-09-24
K903288	Iris Oculight Sl Diode Laser Photocoag/modified	Iriderm Div.	GEX	Class II	1990-09-24
K902871	Optilite Fiberoptic Delivery Systems	Xintec Corporation	GEX	Class II	1990-09-24
K902726	Bartels Extracellular Matrix	Baxter Healthcare Corporation	KIR	Class I	1990-09-24