510(k) · Cleared
ClearedPhysio-Dyne Easi - Lab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Dyne · BZL Computer, Oxygen-Uptake
Cleared on Apr 8, 1993 after a 309-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Apr 8, 1993
- Review
- 309 days
- Class
- Class II
- Product code
- BZL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK922660 Physio-Dyne Easi - LabPhysio-Dyne · 1993
- Descendant · cites it directly · 0 of its ownK973544 Vacu*Med, Gold Edition Carbon Dioxide Gas AnalyzerVacumed, Div. of Vacumetrics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK973545 Vacu*Med Gold Edition Oxygen Gas AnalyzerVacumed, Div. of Vacumetrics, Inc. · 1998
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 |
|---|---|---|---|---|---|
| 0 (this device) | K922660 | Physio-Dyne Easi - Lab | Physio-Dyne | 1993 | — |
| +1 | K973544 | Vacu*Med, Gold Edition Carbon Dioxide Gas Analyzer | Vacumed, Div. of Vacumetrics, Inc. | 1998 | — |
| +1 | K973545 | Vacu*Med Gold Edition Oxygen Gas Analyzer | Vacumed, Div. of Vacumetrics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZL? 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 BZL device
- #1 K190561 NICU V'02score 2.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973544 (Vacumed, Div. of Vacumetrics, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZL devicesBZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZL
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · BZL
Too few BZL 510(k)s in any year since 2007 to give a median.
Recalls per year · BZL
No recall names BZL since 2007.
Adverse event reports per year · BZL
1in 2023
MAUDE reports naming product code BZL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 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 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K922660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922660: Physio-Dyne Easi - Lab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922660
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026