510(k) Report

510(k) · Cleared

Cleared

RB12 Suction Rectal Biopsy System

K062159510(k) TraditionalCleared Sep 5, 200639-day reviewClass II21 CFR 876.1075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aus Systems Pty, Ltd. · FCK Instrument, Biopsy, Suction

Cleared on Sep 5, 2006 as substantially equivalent to K902097 (Medical Measurements, Inc., 1990) after a 39-day review. Its family tree reaches back 1 generation to 1990.

Decided
Sep 5, 2006
Review
39 days
Class
Class II
Product code
FCK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K902097 (1990). No later device cites it as a predicate yet.

K902097 · Model TR Rectal Suction Biopsy Tube · Medical Measurements, Inc. · 19901990199520002005
K902097 · Model TR Rectal Suction Biopsy Tube · Medical Measurements, Inc. · 19900
  1. Root · 1 generation backK902097 Model TR Rectal Suction Biopsy TubeMedical Measurements, Inc. · 1990
  2. This deviceK062159 RB12 Suction Rectal Biopsy SystemAus Systems Pty, Ltd. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902097Model TR Rectal Suction Biopsy TubeMedical Measurements, Inc.1990—
0 (this device)K062159RB12 Suction Rectal Biopsy SystemAus Systems Pty, Ltd.2006—
FIG. 1 — Lineage of K062159, 1990–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K902097Model TR Rectal Suction Biopsy Tube
Summary page 2
…ung's disease. Substantial Equivalence: This device is substantially equivalent to the Model SBT-100 Rectal Suction Biopsy Tool, marketed under K902097 by Medical Measurements, Inc. Description Predicate Device Proposed Dev…
Medical Measurements, Inc.1990—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All FCK devices

FCK Instrument, Biopsy, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCK

1in 2017

2011: 12017: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCK

Too few FCK 510(k)s in any year since 2007 to give a median.

Recalls per year · FCK

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FCK

1in 2025

2015: 22016: 12017: 12022: 32024: 72025: 1
2007high 7 (2024) · low 0 (2007)2025

MAUDE reports naming product code FCK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—10
20120—00
20130—00
20140—00
20150—02
20160—01
20171—01
20180—00
20190—00
20200—00
20210—00
20220—03
20230—00
20240—07
20250—01
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Recent decisions in FCK

The FCK category page

  • K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc. · 2017
  • K103326Multiple Biopsy SystemUnited States Endoscopy Group, Inc. · 2011
  • K061201Dsnare Diminutive Polypectomy and Suction System, Model 00711087United States Endoscopy Group, Inc. · 2006
  • K051637Dsnare, Model 00711087United States Endoscopy Group, Inc. · 2005
  • K954693Mehta Bronchial Biospy DrillUnited States Endoscopy Group, Inc. · 1995

https://510kreport.com/device/K062159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062159: RB12 Suction Rectal Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062159

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026