510(k) · Cleared
ClearedIso-Gard Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · CBN Apparatus, Gas-Scavenging
Cleared on Oct 30, 2014 as substantially equivalent to K132729 (Teleflexmedical, Inc., 2014) after an 86-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Oct 30, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- CBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K863883 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK863883 Models 4002/4102/4202 Oxy. Delivery/CO2 CannulaSalter Labs · 1986
- 3 generations backK961150 Dual Lumen Oxygen Delivery Gas Sampling CannulaHudson Respiratory Care, Inc. · 1996
- 2 generations backK123176 Iso-Gard Clearair MaskTeleflexmedical, Inc. · 2013
- 1 generation backK132729 Iso-Gard MaskTeleflexmedical, Inc. · 2014
- This deviceK142138 Iso-Gard MaskTeleflexmedical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K863883 | Models 4002/4102/4202 Oxy. Delivery/CO2 Cannula | Salter Labs | 1986 | — |
| −3 | K961150 | Dual Lumen Oxygen Delivery Gas Sampling Cannula | Hudson Respiratory Care, Inc. | 1996 | — |
| −2 | K123176 | Iso-Gard Clearair Mask | Teleflexmedical, Inc. | 2013 | — |
| −1 | K132729 | Iso-Gard Mask | Teleflexmedical, Inc. | 2014 | — |
| 0 (this device) | K142138 | Iso-Gard Mask | Teleflexmedical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132729 | Iso-Gard MaskSummary page 4…Classification Panel: Anesthesiology Predicate Device This submission demonstrates substantial equivalence to the predicate device ISO-GARD ClearAir Mask - K132729 Device Description The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WA… | 2014 |
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 28 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All CBN devicesCBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142138: Iso-Gard Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142138
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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