510(k) Report

510(k) · Cleared

Cleared

Passive Waste Gas Scavenger, Model 14600

K080039510(k) TraditionalCleared Apr 14, 200898-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 Apr 14, 2008 as substantially equivalent to K842003 (Ohio Medical Products, 1984) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it.

Decided
Apr 14, 2008
Review
98 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K790333 (1979). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1984: 1 other ancestor2023: 1 descendant cleared2011: 1 descendant clearedK790333 · Nad Scavenging Relief Valve · Draeger Medical, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants K790333 · Nad Scavenging Relief Valve · Draeger Medical, Inc. · 19790
  1. Root · 1 generation backK790333 Nad Scavenging Relief ValveDraeger Medical, Inc. · 1979
  2. This deviceK080039 Passive Waste Gas Scavenger, Model 14600G. Dundas Co.,Inc. · 2008
  3. Descendant · cites it directly · 0 of its ownK223452 Nitronox Scavenger PlusParker Hannifin Corporation · 2023
  4. Descendant · cites it directly · 0 of its ownK101286 Sedara Gas Mixer, Sedara Scavenger Model: 03, 04Linde Healthcare AB · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K223452Nitronox Scavenger PlusParker Hannifin Corporation · 2023 · cites it directly0descendants
  • K101286Sedara Gas Mixer, Sedara Scavenger Model: 03, 04Linde Healthcare AB · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790333Nad Scavenging Relief ValveDraeger Medical, Inc.1979—
0 (this device)K080039Passive Waste Gas Scavenger, Model 14600G. Dundas Co.,Inc.2008—
+1K223452Nitronox Scavenger PlusParker Hannifin Corporation2023—
+1K101286Sedara Gas Mixer, Sedara Scavenger Model: 03, 04Linde Healthcare AB2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202310
FIG. 1 — Lineage of K080039, 1979–2023Source: 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 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 5.3 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K842003Ohio Waste Gas Scavenging Interface
Summary page 2
…Scavenger Classification Name: Apparatus, Gas Scavenging Product Code: CBN Regulation Number: 868.5430 Predicate Devices: K842003 Ohio Waste Gas Scavenging Interface Applicant: Ohio Medical Products K790333 NAD Scavenging Relief Valve Applicant: Drager Medic…
Ohio Medical Products1984—
*K790333Nad Scavenging Relief Valve
Summary page 2
…ode: CBN Regulation Number: 868.5430 Predicate Devices: K842003 Ohio Waste Gas Scavenging Interface Applicant: Ohio Medical Products K790333 NAD Scavenging Relief Valve Applicant: Drager Medical, Inc. Device Description: The Passi…
Draeger Medical, Inc.1979—

Also cleared against K842003: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223452Nitronox Scavenger PlusParker Hannifin Corporation20230
K101286Sedara Gas Mixer, Sedara Scavenger Model: 03, 04Linde Healthcare AB20110

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K223452 (Parker Hannifin Corporation, 2023) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K842003.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Passive Waste Gas Scavenger is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines used during the provision of general anesthesia to adults and children. The Passive Waste Gas Scavenger is designed for use with non-recirculating waste gas disposal systems and is intended for prescription use only.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K080039: Passive Waste Gas Scavenger, Model 14600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080039

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