Data / Medical devices / United States / Verathon Inc.

Verathon Inc.: FDA-registered device maker in Bothell, WA, United States, 7 510(k) clearances

Name: Verathon Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Verathon Inc. is registered with the FDA (registration 3022472) in Bothell, WA, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 3, 2021. 15 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3022472
Address: 20001 North Creek Pkwy, Bothell, WA, United States, 98011
Owner or operator: Verathon Inc. (3022472)
Roles: Manufacturer, Repackager or relabeler
First device listed: August 6, 1992
Registered through: 2026
Brand names listed: BladderScan® BVI 6000 Series, BladderScan® BVI 6100, BladderScan® BVI 6400, BladderScan® Prime, BladderScan® Prime Plus, BladderScan® i10System, US, Console, BladderScan® i10, FloPoint® Elite and more

Devices it lists

Device	Product code	Class	Role	Source
Bronchoscope (Flexible Or Rigid)	EOQ	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Stylet, Tracheal Tube	BSR	1	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov
Uroflowmeter	EXY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2021	K211947	GlideScope BFlex 2.8 Single-Use Bronchoscope	EOQ	Substantially Equivalent	Verathon Medical (Canada) Ulc	accessdata.fda.gov
January 16, 2020	K193488	GlideScope BFlex 3.8 Single-Use Bronchoscope	EOQ	Substantially Equivalent	Verathon Medical (Canada) Ulc	accessdata.fda.gov
August 21, 2019	K191948	GlideScope BFlex 5.8 Single-Use Bronchoscope	EOQ	Substantially Equivalent	Verathon Medical (Canada) Ulc	accessdata.fda.gov
January 4, 2019	K183256	GlideScope BFlex Single-Use Bronchoscope System	EOQ	Substantially Equivalent	Verathon Medical (Canada) Ulc	accessdata.fda.gov
September 15, 2017	K172356	BladderScan Prime PLUS System	IYO	Substantially Equivalent	Verathon Incorporated	accessdata.fda.gov
November 19, 2015	K153101	BladderScan Prime System	IYO	Substantially Equivalent	Verathon Incorporated	accessdata.fda.gov
August 15, 2002	K022153	BLADDERSCAN BVI 6100	IYO	Substantially Equivalent	Diagnostic Ultrasound Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 29, 2024	94547	Class II	Ongoing	Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor	Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.	accessdata.fda.gov
July 1, 2021	88214	Class III	Ongoing	GlideScope Go Monitors	Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.	accessdata.fda.gov
September 29, 2020	86528	Class II	Terminated	BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.	Due to a change in handle material and process, probe handle may crack.	accessdata.fda.gov
June 5, 2020	85705	Class I	Terminated	GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15	When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization interruption, loss of live image/blank screen, no cameras connected monitor warning, may present risk to patients, in which	accessdata.fda.gov
March 31, 2019	84329	Class II	Terminated	GlideScope Video Laryngoscope, Operations & Maintenance Manual, 0900-4940 REV 03	A typographical error in the Operations & Maintenance Manual incorrectly identifies the use of low level disinfection for the reusable video laryngoscope, specifically for the Titanium Blades.	accessdata.fda.gov
March 3, 2017	76642	Class II	Terminated	It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScop	Product labeled as GVL 2 Stat (blades), lot GC32825, was physically packaged with the incorrect size device (GVL 1 Stat (blades)).	accessdata.fda.gov
January 29, 2016	73014	Class I	Terminated	GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portab	The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in use. Video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.	accessdata.fda.gov
November 30, 2015	72642	Class II	Terminated	GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are inte	Certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate, due to inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.	accessdata.fda.gov
November 30, 2015	72486	Class II	Terminated	BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.	The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).	accessdata.fda.gov
April 13, 2015	71008	Class II	Terminated	GlideScope Video Laryngoscope Reusable Blades (GVL 3, 4, 5 and AVL 2, 3, 4, 5). GVL: The GlideScope Video Laryngoscope is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rech	Verathon has revised the Operations and Maintenance Manual (OMM) to specifically state compatibility limitations of the reusable video laryngoscope Blade validated through simulated use cycles, such that exceeding this number of cycles in the specific chemical agent may affect the potential life of the product.	accessdata.fda.gov
May 8, 2013	65129	Class I	Terminated	GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear,	Verathon GlideScope Reusable GVL and AVL Blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.	accessdata.fda.gov
October 25, 2012	63635	Class I	Terminated	The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of	Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to potential cracking.	accessdata.fda.gov
September 20, 2010	56790	Not yet classified	Terminated	The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON ScanPoint Docking Station...Part No. 0570-0168...Bothell, WA USA..."	Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect the transfer of exams and device calibration through QuickPrint interface.	accessdata.fda.gov
August 23, 2010	56411	Not yet classified	Terminated	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obta	The BladderScan BVI 9600 with AortaScan devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.	accessdata.fda.gov
May 18, 2009	52769	Not yet classified	Terminated	The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bladder, and a battery o	Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity.	accessdata.fda.gov

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Updated June 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.