# K062159: RB12 Suction Rectal Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Aus Systems Pty, Ltd.
- Decided: Sep 5, 2006 after 39 days
- Product code: FCK (Instrument, Biopsy, Suction)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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 K902097 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902097: Model TR Rectal Suction Biopsy Tube, Medical Measurements, Inc. (1990) Summary page 2.

## Indications for use
The RBI12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.

Source page: https://510kreport.com/device/K062159
Methodology: https://510kreport.com/methodology