510(k) · Cleared
ClearedModel 9160 VitaloQUB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph Ireland, Ltd. · JEH Plethysmograph, Volume
Cleared on May 25, 2023 as substantially equivalent to K022636 (Morgan Scientific, Inc., 2003) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 25, 2023
- Review
- 155 days
- Class
- Class II
- Product code
- JEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942211 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- 3 generations backK091428 Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010
- 2 generations backK161534 EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017 · Recalled
- 1 generation backK221030 Model 9100 PFT/DICOVitalograph Ireland, Ltd. · 2022
- This deviceK223818 Model 9160 VitaloQUBVitalograph Ireland, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| −3 | K091428 | Easyone Pro Respiratory Analysis System | Ndd Medizitechnik AG | 2010 | — |
| −2 | K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017 | 2 |
| −1 | K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022 | — |
| 0 (this device) | K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 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 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
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 |
|---|---|---|---|
| * | K022636 | Body Box 5500Summary page 4…Plethysmograph, Volume Classification CFR: 21 CFR 868.1760 Product Code: JEH III Primary Predicate Device: K022636 – Morgan Scientific – Medisoft Body Box 5500 Common/Usual Name: Plethysmograph, Volume Classification CFR:… | 2003 |
| * | K221030 | Model 9100 PFT/DICOSummary page 4…Plethysmograph, Volume Classification CFR: 21 CFR 868.1760 Product Code: JEH Secondary Predicate Device: K221030 – Vitalograph Model 9100 PFT/DICO Common/Usual Name: Predictive Pulmonary Function Value Calculator Classific… | 2022 |
| † | K213872 | ComPAS2 | 2022 |
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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All JEH devicesJEH Plethysmograph, Volume: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph
Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained
medical healthcare professionals in a variety of professional healthcare environments e.g., primary care,
hospitals, and pharmaceutical research centers.
The Model 9160 VitaloQUB is a pulmonary function testing device which uses Morgan Scientific’s
ComPAS2 software to measure subject respiratory parameters including FVC, SVC, MVV, CPF, RMS,
SNIP, DLCO, MBN2, SBN2, Thoracic Gas Volume (TGV) and Airway Resistance (Raw)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223818: Model 9160 VitaloQUB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223818
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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