FDA applicant

Performance Hyperbarics

Makawao, HI1 decision2005–20050 recalls

FDA records 1 decision for Performance Hyperbarics (Makawao, HI) in 2005: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). 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 Performance Hyperbarics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Performance Hyperbarics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Performance”

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

Performance Surgical Instruments Corp. 2 Performance Medical, Inc. 1 Performance Instruments Corp. 1 Performance Plus, Inc. 1 Performance, Inc. 1 Performance Water Systems, LLC 1 Performance Ent. 1

Performance Hyperbarics

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Performance”