510(k) Report

FDA applicant

Decibel Instruments, Inc.

Houston, TX2 decisions1996–19970 recalls

FDA records 2 decisions for Decibel Instruments, Inc. (Houston, TX) from 1996 to 1997: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). 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, ear, nose and throat panel, where it files most

How often FDA has decided Decibel Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Decibel Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Decibel Instruments, Inc.’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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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription1decision
  • EWOAudiometer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964603Articular Hearing AidsDecibel Instruments, Inc. · 19963cite it

What has FDA decided for it lately?

  • K973320Articulate Fitting SystemDecibel Instruments, Inc. · 1997
  • K964603Articular Hearing AidsDecibel Instruments, Inc. · 1996

All 2 as Decibel Instruments, Inc. →