510(k) · Cleared
Recalled · 2012Smart Bitebloc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oridion Medical 1987, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Nov 23, 2004 as substantially equivalent to K954352 (United States Endoscopy Group, Inc., 1996) and 5 other predicates after a 55-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 23, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- CCK
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 1 generation to K896691 (1990). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK896691 Bite BlockEndoscopix · 1990
- This deviceK042665 Smart BiteblocOridion Medical 1987, Ltd. · 2004
- 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896691 | Bite Block | Endoscopix | 1990 | — |
| 0 (this device) | K042665 | Smart Bitebloc | Oridion Medical 1987, Ltd. | 2004 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K954352 | Bite BlockSummary page 2…s. Oridion considers this device to be a capnography accessory. SUBSTANTIAL EQUIVALENCE INFORMATION Predicate Devices United States Endoscopy K954352 United States Endoscopy K924304 Endoscopix Bite Block K896691 GI Supply Bite Bloc… | 1996 |
| * | K924304 | Bite BlockSummary page 2…aphy accessory. SUBSTANTIAL EQUIVALENCE INFORMATION Predicate Devices United States Endoscopy K954352 United States Endoscopy K924304 Endoscopix Bite Block K896691 GI Supply Bite Block K915816 GI Supply Oxy-Block K9… | 1993 |
| * | K896691 | Bite BlockSummary page 2…RMATION Predicate Devices United States Endoscopy K954352 United States Endoscopy K924304 Endoscopix Bite Block K896691 GI Supply Bite Block K915816 GI Supply Oxy-Block K931044 Stantex Pty Ltd Oxiguard… | 1990 |
| * | K915816 | Bite Block/Mouthpiece for EndoscopySummary page 2…United States Endoscopy K954352 United States Endoscopy K924304 Endoscopix Bite Block K896691 GI Supply Bite Block K915816 GI Supply Oxy-Block K931044 Stantex Pty Ltd Oxiguard K914978 The Smart BiteBlocTM has the same… | 1992 |
| * | K931044 | Oxy-BlocSummary page 2…United States Endoscopy K924304 Endoscopix Bite Block K896691 GI Supply Bite Block K915816 GI Supply Oxy-Block K931044 Stantex Pty Ltd Oxiguard K914978 The Smart BiteBlocTM has the same intended use as the predicate devices identi… | 1993 |
| * | K914978 | OxyguardSummary page 2…Endoscopix Bite Block K896691 GI Supply Bite Block K915816 GI Supply Oxy-Block K931044 Stantex Pty Ltd Oxiguard K914978 The Smart BiteBlocTM has the same intended use as the predicate devices identified in this section. Any technological differenc… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080527 | Twinguard with Capnograph Accessory | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2012 | Not classified | Z-1333-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
| Feb 16, 2012 | Not classified | Z-1334-2012 | Packaging process control | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 6 ancestors has a recall.
- Of its descendants, K080527 (Trawax Pty Limited, 2008) has gone furthest, with 2 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.
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?
The proposed device, Smart BiteBloc TM, will be used during endoscopy procedures that require a bite block that enables and supports the convenient use of, and will not interfere with, an oral nasal cannula (KO1 1536) for collecting samples of the patient's breathing to measure CO 2 with a capnograph while simultaneously administering supplemental oxygen near the nose for inhalation. It can be used for non intubated patients who weigh more than 55 lbs (25 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042665: Smart Bitebloc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042665
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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