510(k) · Cleared
ClearedSafecircuit Manifold/Pulmonary Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Warming Systems, Inc. · CBN Apparatus, Gas-Scavenging
Cleared on Dec 20, 1996 after a 526-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Dec 20, 1996
- Review
- 526 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK953269 Safecircuit Manifold/Pulmonary UnitAdvanced Warming Systems, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK132729 Iso-Gard MaskTeleflexmedical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK142138 Iso-Gard MaskTeleflexmedical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953269 | Safecircuit Manifold/Pulmonary Unit | Advanced Warming Systems, Inc. | 1996 | — |
| +1 | K123176 | Iso-Gard Clearair Mask | Teleflexmedical, Inc. | 2013 | — |
| +2 | K132729 | Iso-Gard Mask | Teleflexmedical, Inc. | 2014 | — |
| +3 | K142138 | Iso-Gard Mask | Teleflexmedical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
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 K223452 Nitronox Scavenger Plusscore 5.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ohmeda Waste Gas Scavenging interface Named without a submission number | |
| * | — | North American Drager Waste Gas Scavenging interface Named without a submission number | |
| * | — | Dryden SONRA Named without a submission number | |
| * | — | Gibeck-Dryden CO₂ absorber Named without a submission number | |
| * | — | Ohmeda CO₂ absorber Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123176 | Iso-Gard Clearair Mask | 2013 | 2 |
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, K123176 (Teleflexmedical, Inc., 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CBN devicesCBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBN
1in 2023
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
MAUDE reports naming product code CBN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SafeCircuit Manifold/Pulmonary Unit, is intended to be used to scavenging of waste anesthetic gases from patients recovery for general anesthesia and provide supplemental oxygen. When used with the SafeCircuit Adhesive mask and a standard breathing circuit, the unit helps to reduce the amount of anesthetic agents and airborne contaminants released to the work environment of the healthcare worker.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953269: Safecircuit Manifold/Pulmonary Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953269
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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