# K954140: Masterscreen Ios

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger GmbH & Co. KG
- Decided: Dec 14, 1995 after 104 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.
16 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K111053: Sentrysuite Product Line (2011), 11 descendants of its own
- K122699: Sentrysuite Product Line (2012), 9 descendants of its own
- K133925: Vyntus/ Sentrysuite Product Line (2014), 8 descendants of its own
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K101873: Masterscreen Ios (2011), 3 descendants of its own

Source page: https://510kreport.com/device/K954140
Methodology: https://510kreport.com/methodology