FDA applicant

Polar Wrap, LLC

Bonita Springs, FL1 decision2007–20070 recalls

FDA records 1 decision for Polar Wrap, LLC (Bonita Springs, FL) in 2007: 1 510(k) clearance. All are in product code OBN (Humidifier, Respiratory, Mask (Direct Patient…). Its devices cite 2 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, anesthesiology panel, where it files most

How often FDA has decided Polar Wrap, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Polar Wrap, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Polar”

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

Polar Latex, Ltd. 1

Polar Wrap, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Polar”