# Indiba S. A. U.

- Location (FDA's records): Sant Quirze Del Vallès (Barcelona), ES
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Product codes: PBX (2), GEI (1)
- 510(k) review time since 2016: median 114 days, against 130 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (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
- Indiba USA, Inc.: 2 (https://510kreport.com/company/indiba-usa)
- Intelis Instruments, Ltd.: 1 (https://510kreport.com/company/intelis-instruments)
- Venus Concept USA, Inc.: 1 (https://510kreport.com/company/venus-concept-usa)
- Inmode MD, Ltd.: 1 (https://510kreport.com/company/inmode-md)

## Recent decisions
- K241107: Indiba Diathermia Radiofrequency Deep Care Device  (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ  ACT0309/CT9) (Jan 24, 2025)
- K243139: Reverso Pro System (Jan 22, 2025)
- K243164: INDIBA COMPACT devices (Nov 20, 2024)

Source page: https://510kreport.com/company/indiba-s-a-u