# K022103: Puritan-Bennett 700 Renaissance II Spirometry System

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Sep 27, 2002 after 91 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K090646: Cardiotech Spirometry System, Model GT-105 (2009), 1 descendant of its own
- K201493: Spirometer (2021), 0 descendants of its own

## Indications for use
The PB700 Renaissance I1 Spirometry System is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient’s lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician’s offices, laboratories, and occupational health testing environments.

Source page: https://510kreport.com/device/K022103
Methodology: https://510kreport.com/methodology