# K042665: Smart Bitebloc

- Pathway: 510(k) (Traditional)
- Applicant: Oridion Medical 1987, Ltd.
- Decided: Nov 23, 2004 after 55 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896691 (1990). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954352: Bite Block, United States Endoscopy Group, Inc. (1996) Summary page 2.
- K924304: Bite Block, United States Endoscopy Group, Inc. (1993) Summary page 2.
- K896691: Bite Block, Endoscopix (1990) Summary page 2.
- K915816: Bite Block/Mouthpiece for Endoscopy, Gi Supply (1992) Summary page 2.
- K931044: Oxy-Bloc, Gi Supply (1993) Summary page 2.
- K914978: Oxyguard, Stantex Pty, Ltd. (1992) Summary page 2.

## Most influential descendants
- K080527: Twinguard with Capnograph Accessory (2008), 2 descendants of its own
- K140473: Dualguard (2014), 1 descendant of its own
- K240937: AIM (N/A) (2024), 0 descendants of its own

## Recalls of this device
- Feb 16, 2012 · Not classified · Z-1333-2012: 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: CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.

## Indications for use
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).

Source page: https://510kreport.com/device/K042665
Methodology: https://510kreport.com/methodology