510(k) · Cleared
ClearedTwinguard with Capnograph Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trawax Pty Limited · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Oct 31, 2008 as substantially equivalent to K914978 (Stantex Pty, Ltd., 1992) and 2 other predicates after a 248-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 31, 2008
- Review
- 248 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K896691 (1990). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896691 Bite BlockEndoscopix · 1990
- 1 generation backK042665 Smart BiteblocOridion Medical 1987, Ltd. · 2004 · Recalled
- This deviceK080527 Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008
- Descendant · cites it directly · 1 of its ownK140473 DualguardFlexicare Medical, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK240937 AIM (N/A)Inventeur, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896691 | Bite Block | Endoscopix | 1990 | — |
| −1 | K042665 | Smart Bitebloc | Oridion Medical 1987, Ltd. | 2004 | 2 |
| 0 (this device) | K080527 | Twinguard with Capnograph Accessory | Trawax Pty Limited | 2008 | — |
| +1 | K140473 | Dualguard | Flexicare Medical, Ltd. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K914978 | OxyguardSummary page 1…nGuard with Capnograph Accessory is substantially equivalence to the following devices: Stantex Pty Ltd's Oxyguard endoscopic bite block, 5 10O(k) K914978 Hudson Respiratory Care's nasal oxygen cannula, 5 10O(k) KOlI 1125 Oridion Medical's Smart BiteBIoc TM, 5 1… | 1992 |
| * | K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula… | 2001 |
| * | K042665 | Smart BiteblocSummary page 1…copic bite block, 5 10O(k) K914978 Hudson Respiratory Care's nasal oxygen cannula, 5 10O(k) KOlI 1125 Oridion Medical's Smart BiteBIoc TM, 5 10O(k) K042665 Traditional 510(k) 24 February 2008 === Pag… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140473 | Dualguard | 2014 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K140473 (Flexicare Medical, Ltd., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K914978.
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. 2008, 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?
TwinGuard ®, a nasal oxygen cannula and bite block, is used during endoscopy procedures to administer continuous oxygen to the nose and mouth. After endoscopy the bite block is removed, leaving the cannula in place during recovery, to continue delivering oxygen to the nose and mouth. In addition, the TwinGuard ® contains an optional accessory which collects samples of the patient's breathing at the nose and mouth to measure CO 2 with a capnograph during endoscopy procedures. It is intended for adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080527: Twinguard with Capnograph Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080527
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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