510(k) · Cleared
ClearedPuritan Bennett Dataflow Data Management Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BZG Spirometer, Diagnostic
Cleared on Dec 18, 2002 as substantially equivalent to K944762 (Puritan Bennett Corp., 1994) after an 82-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 18, 2002
- Review
- 82 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944762 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- This deviceK023225 Puritan Bennett Dataflow Data Management SoftwarePuritan Bennett Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| 0 (this device) | K023225 | Puritan Bennett Dataflow Data Management Software | Puritan Bennett Corp. | 2002 | — |
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 |
|---|---|---|---|
| * | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data…Summary page 1…ritan-Bennett Renaissance Spirometry System Predicate Device: with the Optional Renaissance DB Data Management Software, 5 10(k) #K944762 Device Description Puritan Bennett DataFlowTMData Management Software is a software program used in conjunction with the Puritan… | 1994 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K944762.
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 Puritan Bennett DataFlowTMData Management Software is intended to augment the Puritan Bennett PB-700 Renaissance@ I1 Spirometer System and the Nellcor Puritan Bennett NPB-500 SimplicityTMSpirometer System’s data management capability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023225 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023225: Puritan Bennett Dataflow Data Management Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023225
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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