# K954382: Prolastic Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Pillar Surgical
- Decided: Nov 29, 1995 after 71 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- 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; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K092590: PDS Plates (2010), 5 descendants of its own
- K132920: Spirox Inex Device (2014), 4 descendants of its own
- K223167: Spirair Nasal Septal Strap (2023), 3 descendants of its own
- K233569: SeptAlign (2024), 2 descendants of its own
- K251790: SeptAlign (2026), 1 descendant of its own

Source page: https://510kreport.com/device/K954382
Methodology: https://510kreport.com/methodology