FDA applicant

Indiba S. A. U.

Sant Quirze Del Vallès (Barcelona), ES3 decisions2024–20250 recalls

FDA records 3 decisions for Indiba S. A. U. (Sant Quirze Del Vallès (Barcelona), ES) from 2024 to 2025: 3 510(k) clearances. Most are in product codes PBX (Massager, Vacuum, Radio Frequency Induced Heat) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Indiba S. A. U.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Indiba S. A. U. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Indiba S. A. U.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Indiba”

FDA records each applicant name separately; these may or may not be the same firm.

Indiba USA, Inc. 1

Indiba S. A. U.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Indiba”