# K062754: Gas Module SE, Model 0998-00-0481-02

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Nov 2, 2006 after 49 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974903 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974903: Gas Module II, Model 0998-00-0143, Datascope Corp. (1998) Summary page 1.
- K001814: Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories, Datex-Ohmeda (2000). Our reading of the summary gave K001114, FDA’s number for 3M Quik Temp Temporization Material (3M Company). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Datex-Ohmeda Compact Airway Module M-CAiOVX and M-COVX”.

## Most influential descendants
- K180788: Gas Module 3 (2018), 0 descendants of its own
- K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (2015), 0 descendants of its own

## Recalls of this device
- Dec 1, 2017 · Class III · Z-1242-2018: The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

## Indications for use
The indications for use for the Gas Module SE include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

Source page: https://510kreport.com/device/K062754
Methodology: https://510kreport.com/methodology