# Kolplast CI SA

- Location (FDA's records): Itupeva- Sp, BR
- FDA decisions: 2 (2011–2017): 2 510(k) clearances
- Names in FDA's records: Kolplast CI SA (1); Kolplast CI Ltda (1)
- Product codes: HHT (1), HIB (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Intl. Cytobrush, Inc.: 1 (https://510kreport.com/company/intl-cytobrush)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)

## Recent decisions
- K153128: Kolplast Cervical Sample Collection Kit (Jan 13, 2017)
- K110766: Kolplux System (Sep 15, 2011)

Source page: https://510kreport.com/company/kolplast-ci