# K973138: Spirocard

- Pathway: 510(k) (Traditional)
- Applicant: Qrs Diagnostic, LLC
- Decided: Oct 28, 1998 after 433 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 K932278 (1993). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932278: PFM Professional 7000 Spirometer, Advanced Medical Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K120880: ORBIT (2012), 0 descendants of its own
- K072722: Meddorna Wireless PRN Spirometer 100 (2008), 0 descendants of its own
- K020004: Clindatalink Version 1.0 for Spirometry (2002), 0 descendants of its own

## Indications for use
Diagnostic Spirometry Patient Population: Male/Female, Pediatric to Adult Device Functionality: Diagnostic Spirometry Spirometric Parameters: FVC, MVV, SVC, and FEF Environment of Use: Hospital, Clinical and Home Utse

Source page: https://510kreport.com/device/K973138
Methodology: https://510kreport.com/methodology