510(k) Report

FDA applicant

Spectro Industries, Inc.

Jenkintown, PA2 decisions1984–19900 recalls

FDA records 2 decisions for Spectro Industries, Inc. (Jenkintown, PA) from 1984 to 1990: 2 510(k) clearances. Most are in product codes LRA (Hearing Aid, Tactile) and FYD (Apparatus, Exhaust, Surgical). 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 Spectro Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectro Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LRAHearing Aid, Tactile1decision
  • FYDApparatus, Exhaust, Surgical1decision

What has FDA decided for it lately?

  • K896822SurgismokeSpectro Industries, Inc. · 1990
  • K843433Kanievski Sensory Aid or DeviceSpectro Industries, Inc. · 1984

All 2 as Spectro Industries, Inc. →