# K944762: Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Dec 13, 1994 after 77 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
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001 (2000), 10 descendants of its own
- K123896: CCS-200 Spirometer (2013), 4 descendants of its own
- K130322: SPM-300 (2013), 3 descendants of its own
- K220535: Cardio10 (2022), 2 descendants of its own
- K022103: Puritan-Bennett 700 Renaissance II Spirometry System (2002), 2 descendants of its own

Source page: https://510kreport.com/device/K944762
Methodology: https://510kreport.com/methodology