510(k) · Cleared
ClearedOxyguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stantex Pty, Ltd. · MNK Endoscopic Bite Block
Cleared on Jan 10, 1992 after a 65-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 10, 1992
- Review
- 65 days
- Class
- Class I
- Product code
- MNK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK914978 OxyguardStantex Pty, Ltd. · 1992
- Descendant · cites it directly · 3 of its ownK042665 Smart BiteblocOridion Medical 1987, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 2 of its ownK080527 Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008
- Descendant · 2 generations on · 1 of its ownK140473 DualguardFlexicare Medical, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK240937 AIM (N/A)Inventeur, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K042665Smart BiteblocOridion Medical 1987, Ltd. · 2004 · cites it directly3descendants
- K080527Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008 · cites it directly2descendants
- K140473DualguardFlexicare Medical, Ltd. · 2014 · 2 generations on1descendant
- K240937AIM (N/A)Inventeur, LLC · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914978 | Oxyguard | Stantex Pty, Ltd. | 1992 | — |
| +1 | K042665 | Smart Bitebloc | Oridion Medical 1987, Ltd. | 2004 | 2 |
| +1 | K080527 | Twinguard with Capnograph Accessory | Trawax Pty Limited | 2008 | — |
| +2 | K140473 | Dualguard | Flexicare Medical, Ltd. | 2014 | — |
| +3 | K240937 | AIM (N/A) | Inventeur, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K042665 (Oridion Medical 1987, Ltd., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MNK devicesMNK Endoscopic Bite Block: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNK
FDA has decided no MNK device since 2007.
Median 510(k) review, days · MNK
Too few MNK 510(k)s in any year since 2007 to give a median.
Recalls per year · MNK
No recall names MNK since 2007.
Adverse event reports per year · MNK
39in 2025
MAUDE reports naming product code MNK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 0 | 39 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K914978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K914978: Oxyguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914978
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026