510(k) Report

510(k) · Cleared

Cleared

Dynamic Gas Scavenging System 2 (DGSS - 2)

K193646510(k) SpecialCleared Dec 4, 2020340-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, Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Dec 4, 2020 as substantially equivalent to K063519 (Anesthetic Gas Reclamation, LLC, 2006) after a 340-day review. Its family tree reaches back 2 generations to 1984.

Decided
Dec 4, 2020
Review
340 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K842003 (1984). No later device cites it as a predicate yet.

  1. Root · 2 generations backK842003 Ohio Waste Gas Scavenging InterfaceOhio Medical Products · 1984
  2. 1 generation backK063519 Dynamic Gas Scavenging System (DGSS)Anesthetic Gas Reclamation, LLC · 2006
  3. This deviceK193646 Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K842003Ohio Waste Gas Scavenging InterfaceOhio Medical Products1984—
−1K063519Dynamic Gas Scavenging System (DGSS)Anesthetic Gas Reclamation, LLC2006—
0 (this device)K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc.2020—
FIG. 1 — Lineage of K193646, 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 5.2 · 2 generations · no Class I recall
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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
*K063519Dynamic Gas Scavenging System (DGSS)
Summary page 5
…on Regulation: 868.5430 Product Code: CBN Device Class: Class II Classification Panel: Anesthesiology 510(k) Number: K063519 Manufacturer: Anesthetic Gas Reclamation, Inc Intended Use: This device is intended to be used for…
Anesthetic Gas Reclamation, LLC2006—

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?

  • The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Dynamic Gas Scavenging System is intended to be used for the scavenging of waste anesthetic gases from anesthesia machines during the provision of general anesthesia to adults and children.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K193646: Dynamic Gas Scavenging System 2 (DGSS - 2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193646

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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