510(k) · Cleared
ClearedOhmeda Model 5330 Anesthetic Agent Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Cleared on Jan 17, 1997 as substantially equivalent to K931439 (Ohmeda Medical, 1993) and 1 other predicate after a 193-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jan 17, 1997
- Review
- 193 days
- Class
- Class II
- Product code
- CBQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K890606 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK890606 Ohmeda 5330 Agent MonitorOhmeda Medical · 1989
- This deviceK962648 Ohmeda Model 5330 Anesthetic Agent MonitorOhmeda Medical · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890606 | Ohmeda 5330 Agent Monitor | Ohmeda Medical | 1989 | — |
| 0 (this device) | K962648 | Ohmeda Model 5330 Anesthetic Agent Monitor | Ohmeda Medical | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 CBQ? 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931439 | Ohmeda Model 5330 Anesthetic MonitorSummary page 1…620 Class II) Predicate Devi The predicate device is the current version of the same device, the Ohmeda Model 5330 Anesthetic Agent Monitor (4 agent version), 510 (k) # K931439, and the previous version which was the Ohmeda Model 5330 Anesthetic Agent Monitor (3 agent version), 510(k) #K890606. These pred… | 1993 |
| * | K890606 | Ohmeda 5330 Agent MonitorSummary page 1…esthetic Agent Monitor (4 agent version), 510 (k) # K931439, and the previous version which was the Ohmeda Model 5330 Anesthetic Agent Monitor (3 agent version), 510(k) #K890606. These predicate devices have the same performance specifications as the five agent version being proposed, they just monitor few… | 1989 |
| Kept off the family tree | X920590 | Ohmeda Model 5250 RGM Monitor Number could not be read Summary page 1…ame performance specifications as the five agent version being proposed, they just monitor fewer agents. Another predicate device is the Ohmeda Model 5250 RGM Monitor, # X920590, which features an anesthetic agent monitor. The 5250 can monitor sevoflurane. The Ohmeda Model 5330 Anesthetic Agent Monitor (4… |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All CBQ devicesCBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBQ
FDA has decided no CBQ device since 2007.
Median 510(k) review, days · CBQ
Too few CBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CBQ
No recall names CBQ since 2007.
Adverse event reports per year · CBQ
1in 2022
MAUDE reports naming product code CBQ, 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 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962648: Ohmeda Model 5330 Anesthetic Agent Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962648
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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