# Timpel S.A.

- Location (FDA's records): Sao Paulo, BR
- FDA decisions: 4 (2018–2025): 3 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Timpel S.A. (3); Timpel, Inc. (1)
- Product codes: QEB (4)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 5 (3 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
- Respironics Novametrix, Inc.: 1 (https://510kreport.com/company/respironics-novametrix)

## Firms that cite its devices most
- Bilab: 1 (https://510kreport.com/company/bilab)
- Sentec AG: 1 (https://510kreport.com/company/sentec)

## Its most-cited devices
- K222897: Enlight 2100 (2023), cited by 2
- K211135: Enlight 2100 (2022), cited by 2
- DEN170072: Enlight 1810 (2018), cited by 1

## Recent decisions
- K250464: Enlight 2100 (TPL-E2103-0) (Sep 10, 2025)
- K222897: Enlight 2100 (Mar 7, 2023)
- K211135: Enlight 2100 (Jan 6, 2022)
- DEN170072: Enlight 1810 (Dec 20, 2018)

Source page: https://510kreport.com/company/timpel