510(k) · Cleared
ClearedGas Module II, Model 0998-00-0143
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Cleared on Mar 13, 1998 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 13, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- CBS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK974903 Gas Module II, Model 0998-00-0143Datascope Corp. · 1998
- Descendant · cites it directly · 2 of its ownK062754 Gas Module SE, Model 0998-00-0481-02Datascope Corp. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK180788 Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K062754Gas Module SE, Model 0998-00-0481-02Datascope Corp. · 2006 · cites it directly2descendants
- K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018 · 2 generations on0descendants
- K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974903 | Gas Module II, Model 0998-00-0143 | Datascope Corp. | 1998 | — |
| +1 | K062754 | Gas Module SE, Model 0998-00-0481-02 | Datascope Corp. | 2006 | 1 |
| +2 | K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +2 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBS? 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K062754 | Gas Module SE, Model 0998-00-0481-02 | 2006 | 2 |
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, K062754 (Datascope Corp., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CBS devicesCBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBS
FDA has decided no CBS device since 2007.
Median 510(k) review, days · CBS
Too few CBS 510(k)s in any year since 2007 to give a median.
Recalls per year · CBS
No recall names CBS since 2007.
Adverse event reports per year · CBS
2in 2025
MAUDE reports naming product code CBS, 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 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use for the Gas Module II 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974903: Gas Module II, Model 0998-00-0143.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974903
Report an extraction error
Are you the manufacturer?
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