510(k) Report

510(k) · Cleared

Cleared

Dynamic Gas Scavenging System (DGSS)

K063519510(k) TraditionalCleared Dec 1, 200610-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

Anesthetic Gas Reclamation, LLC · CBN Apparatus, Gas-Scavenging

Cleared on Dec 1, 2006 as substantially equivalent to K842003 (Ohio Medical Products, 1984) after a 10-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided
Dec 1, 2006
Review
10 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K842003 (1984). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant clearedK842003 · Ohio Waste Gas Scavenging Interface · Ohio Medical Products · 198419801990200020102020
Descendants, by generation 1 generation forward: 1 descendant K842003 · Ohio Waste Gas Scavenging Interface · Ohio Medical Products · 19840
  1. Root · 1 generation backK842003 Ohio Waste Gas Scavenging InterfaceOhio Medical Products · 1984
  2. This deviceK063519 Dynamic Gas Scavenging System (DGSS)Anesthetic Gas Reclamation, LLC · 2006
  3. Descendant · cites it directly · 0 of its ownK193646 Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K842003Ohio Waste Gas Scavenging InterfaceOhio Medical Products1984—
0 (this device)K063519Dynamic Gas Scavenging System (DGSS)Anesthetic Gas Reclamation, LLC2006—
+1K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K063519, 1984–2020Source: 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 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
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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
*K842003Ohio Waste Gas Scavenging Interface
Summary page 1
…e anesthetic gases Classification Name: Apparatus, Gas Scavenging Product Code: CBN Regulation Number: 868.5430 Predicate Device: K842003 - Ohio Waste Gas Scavenging Reservoir 9 ===…
Ohio Medical Products1984—

Also cleared against K842003: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.20200

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.
  • Of its descendants, K193646 (Anesthetic Gas Reclamation, Inc., 2020) 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.

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 DGSSTM 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K063519: Dynamic Gas Scavenging System (DGSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063519

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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