510(k) · Cleared
ClearedModel 9100 PFT/DICO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph Ireland, Ltd. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Jul 15, 2022 as substantially equivalent to K161534 (Ndd Medizintechnik AG, 2017) after a 99-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jul 15, 2022
- Review
- 99 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942211 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- 2 generations backK091428 Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010
- 1 generation backK161534 EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017 · Recalled
- This deviceK221030 Model 9100 PFT/DICOVitalograph Ireland, Ltd. · 2022
- 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 |
|---|---|---|---|---|---|
| −3 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| −2 | K091428 | Easyone Pro Respiratory Analysis System | Ndd Medizitechnik AG | 2010 | — |
| −1 | K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017 | 2 |
| 0 (this device) | K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022 | — |
| +1 | K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 BTY? 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 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 |
|---|---|---|---|
| * | K161534 | EasyOne Pro Respiratory Analysis SystemSummary page 4…ction Value Calculator Classification CFR: 21 CFR 868.1890 Product Code: BTY III Predicate Device: NDD - K161534 – EasyOne Pro Lab Common/Usual Name: Predictive Pulmonary Function Value Calculator Classification CFR:… | 2017 |
| † | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART… | 2018 |
| † | K042595 | Spiro'air | 2005 |
| † | K030917 | Gem; Hawk; Eagle; Models 004110, 0044120, 004130 | 2003 |
| † | K971084 | Model 02 Oxygen Analyzer | 1998 |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K223818 (Vitalograph Ireland, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Model 9100 PFT/DlCO 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 and SBN2.
The device is PC-based and designed for lung function testing on adults and pediatrics, 6 years and older, in a variety of professional healthcare environments e.g., primary care, hospitals, pharmaceutical research centers and physicians’ offices.
The Model 9100 PFT/DlCO is intended for the assessment of respiratory function through the measurement of dynamic lung volumes i.e., spirometry and other lung functions i.e., diffusing capacity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221030: Model 9100 PFT/DICO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221030
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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