# K992152: General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Aug 17, 1999 after 53 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851895 (1985). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851895: Polygel Ultrasound Gel, Parker Laboratories, Inc. (1985) Summary page 4.
- K873159: Combison (R) 310A Real Time Ultrasound Scanner, Cone Instruments, Inc. (1988) Summary page 4.
- K936024: Ultrasound Scanner 2001, B & K Medical A/S (1995) Summary page 4.
- K943315: Ultrasound Scanner 2002, B&K Medical (1996) Summary page 4.
- K905198: Diagnostic Ultrasound System Type 3535, Bruel & Kjaer (1991) Summary page 4.
- K914945: Diagnostic Ultrasound System Type 3535, Modified, Bruel & Kjaer Industri A/S (1992) Summary page 4.
- K933056: Diagnostic Ultrasound System Type 3535, Modified, B&K Medical (1994) Summary page 4.

## Most influential descendants
- K080119: Clearscan (2008), 0 descendants of its own

## Indications for use
The Ultrasound Transducer Standoff is placed over a diagnostic ultrasound transducer / probe / scanhead to control the distance (offset) between transducer and body surfaces for optimal focusing by shifting the transducer, effectively offsetting the focal zone, for improved visualization of near-field and superficial structures. The transducer standoff device can be used to perform scanning and needle guided procedures for body surface and endocavity diagnostic ultrasound. Standoff devices are furnished as a non-sterile; single use patient / procedure, with limited reuse capability (as designated in instructions for use) if properly cleaned / disinfected between patient uses.

Source page: https://510kreport.com/device/K992152
Methodology: https://510kreport.com/methodology