510(k) Report

FDA applicant

Bio-Medical Sciences, Inc.

Bethlehem, PA3 decisions1978–19980 recalls

FDA records 3 decisions for Bio-Medical Sciences, Inc. (Bethlehem, PA) from 1978 to 1998: 3 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and MMQ (Topographer, Corneal, Ac-Powered). 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, general hospital panel, where it files most

How often FDA has decided Bio-Medical Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Medical Sciences, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Medical Sciences, 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?

  • JOJIndicator, Physical/Chemical Sterilization Process2decisions
  • MMQTopographer, Corneal, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K813202Thermalog S Steam Sterilization IntegraBio-Medical Sciences, Inc. · 19811cites it

What has FDA decided for it lately?

  • K981665Silon Topomat Corneal Topography Image Enhancement DeviceBio-Medical Sciences, Inc. · 1998
  • K813202Thermalog S Steam Sterilization IntegraBio-Medical Sciences, Inc. · 1981
  • K772358Ethylene Oxide Sterili. IndicatorBio-Medical Sciences, Inc. · 1978

All 3 as Bio-Medical Sciences, Inc. →