510(k) · Cleared
ClearedVacu*Med Gold Edition Oxygen Gas Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vacumed, Div. of Vacumetrics, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on May 26, 1998 as substantially equivalent to K922660 (Physio-Dyne, 1993) after a 250-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- May 26, 1998
- Review
- 250 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922660 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK922660 Physio-Dyne Easi - LabPhysio-Dyne · 1993
- This deviceK973545 Vacu*Med Gold Edition Oxygen Gas AnalyzerVacumed, Div. of Vacumetrics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922660 | Physio-Dyne Easi - Lab | Physio-Dyne | 1993 | — |
| 0 (this device) | K973545 | Vacu*Med Gold Edition Oxygen Gas Analyzer | Vacumed, Div. of Vacumetrics, Inc. | 1998 | — |
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 CCL? 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 CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K922660 | Physio-Dyne Easi - LabSummary page 1…ion: 1. Predicate Device Identification: A claim of substantial equivalence of the VacueMed, Gold Edition, Oxygen Gas Analyzer is made to the: . PHYSIO-DYNE Easi-Lab, K922660. This device was marketed after May 28, 1976 and has received FDA clearance to market since that date. 2. Statement of Biocomp… | 1993 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K922660.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.
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/K973545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973545: Vacu*Med Gold Edition Oxygen Gas Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973545
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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