# K954192: Impregum Penta

- Pathway: 510(k) (Traditional)
- Applicant: Espe GmbH & Co. Kg.
- Decided: Dec 1, 1995 after 86 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K992897: Impregum Penta (1999), 4 descendants of its own
- K994192: Impregum Penta M Monosoft (2000), 3 descendants of its own
- K032001: Poly Q (Garant L, Penta M, Penta H) (2003), 2 descendants of its own
- K173318: Rapid HB, Rapid LB, Rapid MB (2017), 0 descendants of its own
- K080514: Pecd-01 and Pecd Quick-01 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K954192
Methodology: https://510kreport.com/methodology