510(k) · Cleared
ClearedPFM Professional 7000 Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Systems, Inc. · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Dec 17, 1993 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 17, 1993
- Review
- 219 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK932278 PFM Professional 7000 SpirometerAdvanced Medical Systems, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK973138 SpirocardQrs Diagnostic, LLC · 1998
- Descendant · 2 generations on · 0 of its ownK120880 ORBITNational Biomedical, LLC Dba Qrs Diagnostic · 2012
- Descendant · 2 generations on · 0 of its ownK072722 Meddorna Wireless PRN Spirometer 100Meddorna, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK020004 Clindatalink Version 1.0 for SpirometryCompleware Corp. · 2002
Most influential descendants
Showing 4 of 4 · See all- K973138SpirocardQrs Diagnostic, LLC · 1998 · cites it directly3descendants
- K120880ORBITNational Biomedical, LLC Dba Qrs Diagnostic · 2012 · 2 generations on0descendants
- K072722Meddorna Wireless PRN Spirometer 100Meddorna, LLC · 2008 · 2 generations on0descendants
- K020004Clindatalink Version 1.0 for SpirometryCompleware Corp. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932278 | PFM Professional 7000 Spirometer | Advanced Medical Systems, Inc. | 1993 | — |
| +1 | K973138 | Spirocard | Qrs Diagnostic, LLC | 1998 | — |
| +2 | K120880 | ORBIT | National Biomedical, LLC Dba Qrs Diagnostic | 2012 | — |
| +2 | K072722 | Meddorna Wireless PRN Spirometer 100 | Meddorna, LLC | 2008 | — |
| +2 | K020004 | Clindatalink Version 1.0 for Spirometry | Compleware Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973138 | Spirocard | 1998 | 3 |
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, K973138 (Qrs Diagnostic, LLC, 1998) has gone furthest, with 3 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.
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 | — |
https://510kreport.com/device/K932278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K932278: PFM Professional 7000 Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932278
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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