# K022153: Bladderscan Bvi 6100

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Ultrasound Corp.
- Decided: Aug 15, 2002 after 44 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915436 (1992). 4 ancestors in all.
47 later devices descend from it; 3 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955840: Bladdermanager Pci 5000 / Bladderscan Bvi 5000, Diagnostic Ultrasound Corp. (1996). Our reading of the summary gave K955850, FDA’s number for Pro-Tech (Central Solutions, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Diagnostic Ultrasound BladderManager BVI 5000 System”.
- K915436: Bladderscan Bvi 2500, Diagnostic Ultrasound Corp. (1992) Summary page 2.
- K990806: C1 Ultrasound System, Sonosite,Inc. (1999) Summary page 2.

## Most influential descendants
- K071217: Bladderscan Bvi 9400 Ultrasound (2007), 45 descendants of its own
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System (2009), 16 descendants of its own
- K111021: Cubescan / Biocon-700 (2011), 13 descendants of its own
- K131227: Padscan HD Series Bladder Scanner (2013), 7 descendants of its own
- K130229: Palm Bladder Scanner (2013), 7 descendants of its own

## Recalls of this device
- Sep 20, 2010 · Not classified · Z-0143-2011: 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 Q

## Indications for use
The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound’s predicate devices. The Bladderscan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.

Source page: https://510kreport.com/device/K022153
Methodology: https://510kreport.com/methodology