510(k) · Cleared
ClearedOxy-Bloc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gi Supply · MNK Endoscopic Bite Block
Cleared on Oct 4, 1993 after a 217-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
- Oct 4, 1993
- Review
- 217 days
- Class
- Class I
- Product code
- MNK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK931044 Oxy-BlocGi Supply · 1993
- Descendant · cites it directly · 3 of its ownK042665 Smart BiteblocOridion Medical 1987, Ltd. · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK080527 Twinguard with Capnograph AccessoryTrawax Pty Limited · 2008
- Descendant · 3 generations on · 1 of its ownK140473 DualguardFlexicare Medical, Ltd. · 2014
- Descendant · 4 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 · 2 generations on2descendants
- K140473DualguardFlexicare Medical, Ltd. · 2014 · 3 generations on1descendant
- K240937AIM (N/A)Inventeur, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931044 | Oxy-Bloc | Gi Supply | 1993 | — |
| +1 | K042665 | Smart Bitebloc | Oridion Medical 1987, Ltd. | 2004 | 2 |
| +2 | K080527 | Twinguard with Capnograph Accessory | Trawax Pty Limited | 2008 | — |
| +3 | K140473 | Dualguard | Flexicare Medical, Ltd. | 2014 | — |
| +4 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042665 | Smart Bitebloc | 2004 | 3 |
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/K931044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K931044: Oxy-Bloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931044
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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