# K023225: Puritan Bennett Dataflow Data Management Software

- Pathway: 510(k) (Abbreviated)
- Applicant: Puritan Bennett Corp.
- Decided: Dec 18, 2002 after 82 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944762 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944762: Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware, Puritan Bennett Corp. (1994) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K023225
Methodology: https://510kreport.com/methodology