# K946075: Vitalograph Model 2120

- Pathway: 510(k) (Traditional)
- Applicant: Vitalograph, Inc.
- Decided: Aug 4, 1995 after 242 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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
- 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
- K142812: Vitalograph Model 6800 Pneumotrac (2015), 1 descendant of its own
- K251777: MESI mTABLET SPIRO (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K946075
Methodology: https://510kreport.com/methodology