# K001995: Spiroxcard Diagnostic Spirometer and Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Qrs Diagnostic, LLC
- Decided: Sep 8, 2000 after 70 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 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
- K031515: Spiropro SPO2 (2003), 10 descendants of its own
- K092324: Spiropro (2009), 9 descendants of its own
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), 6 descendants of its own
- K200550: Vitalograph Model 2120 In2itive eDiary (2020), 2 descendants of its own
- K212938: Vitalograph Model 6000 Alpha (2022), 1 descendant of its own

Source page: https://510kreport.com/device/K001995
Methodology: https://510kreport.com/methodology