510(k) · Cleared
ClearedBody Box 5500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morgan Scientific, Inc. · JEH Plethysmograph, Volume
Cleared on Jan 13, 2003 after a 158-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 13, 2003
- Review
- 158 days
- Class
- Class II
- Product code
- JEH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK022636 Body Box 5500Morgan Scientific, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK223818 Model 9160 VitaloQUBVitalograph Ireland, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022636 | Body Box 5500 | Morgan Scientific, Inc. | 2003 | — |
| +1 | K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 JEH? 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 JEH device
- #1 K240706 PowerCube+ Series (PowerCube Body+)…score 8.5 · 1 generation · no Class I recall
- #2 Held for the reportin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223818 | Model 9160 VitaloQUB | 2023 | 0 |
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, K223818 (Vitalograph Ireland, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JEH devicesJEH Plethysmograph, Volume: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JEH
Too few JEH 510(k)s in any year since 2007 to give a median.
Recalls per year · JEH
No recall names JEH since 2007.
Adverse event reports per year · JEH
1in 2024
MAUDE reports naming product code JEH, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 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 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022636: Body Box 5500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022636
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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