# K911143: PB100 Diagnostic Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Nov 29, 1991 after 260 days
- Product code: BZM (Calculator, Pulmonary Function Interpretor (Diagnostic))
- Device class: 2
- Regulation: 21 CFR 868.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K954759: Flowmate Lte (1996), 1 descendant of its own
- K982956: Flowmate II Plus, Model #4000 (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K911143
Methodology: https://510kreport.com/methodology