510(k) · Cleared
ClearedAlerkan Spirometry Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alerkan, Ltd. · BZG Spirometer, Diagnostic
Cleared on Oct 20, 2011 after a 135-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 20, 2011
- Review
- 135 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs. Adaptable for use with the following PFT equipment: Model 9502: Approx. 30 mm ID × 34 mm OD; fits Viasys, SensorMedics, Jeager. Model 9503: Approx. 26.5 mm ID × 30 mm OD; fits MIR, Zan, nSpire, Micro Medical, Datospir. Model 9504…
Read the full statement (134 words)
For use with pulmonary function testing (PFT) equipment only. To filter air between the patient's exhaled air and the testing equipment. Single patient use, single session, and disposable. Maximum duration of use is 24 hrs.
Adaptable for use with the following PFT equipment:
Model 9502: Approx. 30 mm ID × 34 mm OD; fits Viasys, SensorMedics, Jeager.
Model 9503: Approx. 26.5 mm ID × 30 mm OD; fits MIR, Zan, nSpire, Micro Medical, Datospir.
Model 9504: Approx. 45 mm ID × 48.5 mm; fits Koko Spirometer, KoKo Legend, and Koko Trek.
Model 9505: Approx. 30 mm ID × 34 mm OD and approx. 26.5 mm ID × 30 mm OD; fits Viasys, SensorMedics, Jeager, MIR, Zan, nSpire, Micro Medical, Datospir.
Environment of Use -- Hospital, Sub-acute Institutions, Doctor's offices, Laboratories
Target Patient Populations: Adults
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111587: Alerkan Spirometry Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111587
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026