510(k) · Cleared
ClearedCollins CPL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collins Medical, Inc. · BZG Spirometer, Diagnostic
Cleared on Sep 13, 1999 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Sep 13, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK992743 Collins CPLCollins Medical, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK052328 Zan Lung-Function LabZan Messgerate GmbH · 2005
- Descendant · 2 generations on · 3 of its ownK133051 Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK141793 Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK161295 MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK030464 Gem, Model 004110Collins Medical, Inc. · 2003
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052328Zan Lung-Function LabZan Messgerate GmbH · 2005 · cites it directly4descendants
- K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd. · 2014 · 2 generations on3descendants
- K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd. · 2015 · 3 generations on2descendants
- K161295MiniBox +Pulmone Advanced Medical Devices, Ltd. · 2016 · 2 generations on1descendant
- K030464Gem, Model 004110Collins Medical, Inc. · 2003 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992743 | Collins CPL | Collins Medical, Inc. | 1999 | — |
| +1 | K052328 | Zan Lung-Function Lab | Zan Messgerate GmbH | 2005 | — |
| +2 | K133051 | Pulmone Minibox PFT TM | Pulmone Advanced Medical Devices, Ltd. | 2014 | — |
| +3 | K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | 2015 | — |
| +2 | K161295 | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | 2016 | — |
| +1 | K030464 | Gem, Model 004110 | Collins Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
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? (7)
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?
- Of its descendants, K052328 (Zan Messgerate GmbH, 2005) has gone furthest, with 4 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?
The Collins CPL Pulmonary Function Test System is intended as a configuraple non-invasive pulmonary function testing (PFT), and exercise/nutritional/metabolic testing system. Complete plethysmography capabilities are an optional module. These tests are suitable for both pediatric and adult patient testing.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992743 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992743: Collins CPL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992743
Report an extraction error
Are you the manufacturer?
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