FDA applicant

Omnia Spa

Carmel, IN3 decisions2011–20180 recalls

FDA records 3 decisions for Omnia Spa (Carmel, IN) from 2011 to 2018: 3 510(k) clearances. Most are in product codes NBY (Suture, Surgical, Nonabsorbable, Expanded…) and FYA (Gown, Surgical). Its devices cite 1 predicate, 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 Omnia Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Omnia Spa by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omnia Spa’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 “Omnia”

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

Omnia Medical, LLC 11

Omnia Spa

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Omnia”