510(k) · Cleared
Recalled · Class III · 2017Gas Module SE, Model 0998-00-0481-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · BZK Spirometer, Monitoring (W/Wo Alarm)
Cleared on Nov 2, 2006 as substantially equivalent to K974903 (Datascope Corp., 1998) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- BZK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974903 (1998). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974903 Gas Module II, Model 0998-00-0143Datascope Corp. · 1998
- This deviceK062754 Gas Module SE, Model 0998-00-0481-02Datascope Corp. · 2006
- Descendant · cites it directly · 0 of its ownK180788 Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974903 | Gas Module II, Model 0998-00-0143 | Datascope Corp. | 1998 | — |
| 0 (this device) | K062754 | Gas Module SE, Model 0998-00-0481-02 | Datascope Corp. | 2006 | — |
| +1 | K180788 | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| +1 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 BZK? 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 BZK device
- #1 K260226 ElintMAX Respiratory Monitor (ElintMAX Monitor…score 19.5 · 26 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974903 | Gas Module II, Model 0998-00-0143Summary page 1…68.1620 - Analyzer, Gas, Halotbane, Gaseous- Phase (Anesthetic Conc.) 21 CFR 868.1850 - Spirometer, Monitoring (w/wo alarm) Predicate Devices: K974903 Gas Module II K01 814 Datex-Ohmieda Compact Airway Module M-CAiOVX and M-COVX Device Description: The… | 1998 |
| * | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories 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”. | 2000 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2017 | Class III | Z-1242-2018 | Device Design | The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K180788 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZK devicesBZK Spirometer, Monitoring (W/Wo Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZK
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · BZK
71in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZK
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZK
2in 2020
MAUDE reports naming product code BZK, 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 | 1 | — | 0 | 0 |
| 2009 | 3 | 71 | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062754: Gas Module SE, Model 0998-00-0481-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062754
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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