510(k) · Cleared
ClearedDualguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Apr 10, 2014 as substantially equivalent to K080527 (Trawax Pty Limited, 2008) after a 44-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Apr 10, 2014
- Review
- 44 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896691 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896691 Bite BlockEndoscopix · 1990
- 2 generations backK042665 Smart BiteblocOridion Medical 1987, Ltd. · 2004 · Recalled
- 1 generation backK080527 Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008
- This deviceK140473 DualguardFlexicare Medical, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK240937 AIM (N/A)Inventeur, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240937AIM (N/A)Inventeur, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896691 | Bite Block | Endoscopix | 1990 | — |
| −2 | K042665 | Smart Bitebloc | Oridion Medical 1987, Ltd. | 2004 | 2 |
| −1 | K080527 | Twinguard with Capnograph Accessory | Trawax Pty Limited | 2008 | — |
| 0 (this device) | K140473 | Dualguard | Flexicare Medical, Ltd. | 2014 | — |
| +1 | K240937 | AIM (N/A) | Inventeur, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K080527 | Twinguard with Capnograph AccessorySummary page 1…bite block (MNK), Nasal oxygen cannula (CAT) Legally Marketed Equivalent Device: The DualGuar1TM is substantially equivalent to Trawax's TwinGuard® cleared under 51 0(k) K080527. Device Description: DualGuardTM is an endloscopic bite block which is designed to fit into the nose and mouth of the patient d… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240937 | AIM (N/A) | 2024 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K240937 (Inventeur, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
DualGuardTM is intended for use in Adult patients who require supplemental oxygen delivery and C02 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures.
The DualGuardTM Bite Block is to be removed after endoscopy, leaving the 02 delivering/C02 sampling cannula in place for patient recovery period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140473: Dualguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140473
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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