510(k) · Cleared
ClearedSpirocard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qrs Diagnostic, LLC · BZG Spirometer, Diagnostic
Cleared on Oct 28, 1998 as substantially equivalent to K932278 (Advanced Medical Systems, Inc., 1993) after a 433-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Oct 28, 1998
- Review
- 433 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932278 (1993). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK932278 PFM Professional 7000 SpirometerAdvanced Medical Systems, Inc. · 1993
- This deviceK973138 SpirocardQrs Diagnostic, LLC · 1998
- Descendant · cites it directly · 0 of its ownK120880 ORBITNational Biomedical, LLC Dba Qrs Diagnostic · 2012
- Descendant · cites it directly · 0 of its ownK072722 Meddorna Wireless PRN Spirometer 100Meddorna, LLC · 2008
- Descendant · cites it directly · 0 of its ownK020004 Clindatalink Version 1.0 for SpirometryCompleware Corp. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932278 | PFM Professional 7000 Spirometer | Advanced Medical Systems, Inc. | 1993 | — |
| 0 (this device) | K973138 | Spirocard | Qrs Diagnostic, LLC | 1998 | — |
| +1 | K120880 | ORBIT | National Biomedical, LLC Dba Qrs Diagnostic | 2012 | — |
| +1 | K072722 | Meddorna Wireless PRN Spirometer 100 | Meddorna, LLC | 2008 | — |
| +1 | K020004 | Clindatalink Version 1.0 for Spirometry | Compleware Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 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 |
|---|---|---|---|
| * | K932278 | PFM Professional 7000 SpirometerSummary page 1…atory Affairs Ext: 924 TRADE NAME: SpiroCard CLASSIFICATION NAME: Diagnostic Spirometer CLASSIFICATION: Class II, according to 21 CFR, 868.1840 MODIFICATION OF: 510[k] #K932278, Advanced Medical Systems Corp. PFM Professional 7000 DEVICE SUMMARY: The SpiroCard is a spirometery diagnostic device that meas… | 1993 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K120880 (National Biomedical, LLC Dba Qrs Diagnostic, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Diagnostic Spirometry
Patient Population: Male/Female, Pediatric to Adult
Device Functionality: Diagnostic Spirometry
Spirometric Parameters: FVC, MVV, SVC, and FEF
Environment of Use: Hospital, Clinical and Home Utse
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973138: Spirocard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973138
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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