# K980441: Spirometer Model NPB-500

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Apr 30, 1998 after 85 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 2.
- K946075: Vitalograph Model 2120, Vitalograph, Inc. (1995) Summary page 1.

## Indications for use
The NPB-500 Spirometry System’s intended use is simple diagnostic forced vital capacity (FVC) testing for adults of all ages plus pediatric patients, in the patient examination rooms of a physician’s practice and in hospital or hospital-type facilities such as respiratory care centers. The NPB 500 Spirometry System is for prescription use only.

Source page: https://510kreport.com/device/K980441
Methodology: https://510kreport.com/methodology