510(k) Report

510(k) · Cleared

Cleared

Active Waste Gas Scavenger

K110930510(k) SpecialCleared Jun 23, 201180-day reviewClass II21 CFR 868.5430

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

G. Dundas Co.,Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Jun 23, 2011 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Jun 23, 2011
Review
80 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2010201520202025
  1. This deviceK110930 Active Waste Gas ScavengerG. Dundas Co.,Inc. · 2011
  2. Descendant · cites it directly · 0 of its ownK160950 MiniscavSedation Systems, LLC · 2017 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K160950MiniscavSedation Systems, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K110930Active Waste Gas ScavengerG. Dundas Co.,Inc.2011—
+1K160950MiniscavSedation Systems, LLC20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K110930, 2011–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

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

Top candidate predicates for a new CBN device

  1. #1 K223452 Nitronox Scavenger Plusscore 5.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160950MiniscavSedation Systems, LLC20170

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?

  • Of its descendants, K160950 (Sedation Systems, LLC, 2017) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · CBN

1in 2023

2007: 12008: 12010: 12011: 12013: 12014: 22017: 12020: 12023: 1
2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBN

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

Recalls per year · CBN

No recall names CBN since 2007.

Adverse event reports per year · CBN

1in 2025

2012: 12015: 12020: 22025: 1
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code CBN, 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
20071—00
20081—00
20090—00
20101—00
20111—00
20120—01
20131—00
20142—00
20150—01
20160—00
20171—00
20180—00
20190—00
20201—02
20210—00
20220—00
20231—00
20240—00
20250—01
20260—0—

What is it indicated for?

The Waste Gas Scavenger is designed for use with vacuum (suction) waste gas disposal systems with anesthesia machines and heart/lung bypass machines.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K110930: Active Waste Gas Scavenger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110930

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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