510(k) Report

FDA applicant

North American Science Assoc., Inc.

Toledo, OH6 decisions1997–20140 recalls

FDA records 6 decisions for North American Science Assoc., Inc. (Toledo, OH) from 1997 to 2014: 6 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and JOJ (Indicator, Physical/Chemical Sterilization…). Its devices cite 7 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 North American Science Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2012: 22014: 2
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — North American Science Assoc., 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?

  • FRCIndicator, Biological Sterilization Process3decisions
  • JOJIndicator, Physical/Chemical Sterilization Process2decisions
  • MTCIndicator, Chemical, Enzymatic, Sterilization Process1decision

Whose devices does it build on?

Its devices cite 7 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.

  • K962649Sportrol Rapid Sterility IndicatorNorth American Science Assoc., Inc. · 19971cites it

What has FDA decided for it lately?

  • K141244Namsa Biological Indicator Spore Strips (Dual Species) Namsa Biological Indicator Spore Strips (Single…North American Science Assoc., Inc. · 2014
  • K132291Namsa Chemical ProcessNorth American Science Assoc., Inc. · 2014
  • K113221Namsa Biological Indicator Spore StripsNorth American Science Assoc., Inc. · 2012
  • K113302Namsa Steam Self-Contained Biological IndicatorsNorth American Science Assoc., Inc. · 2012
  • K983451Challenge Test PackNorth American Science Assoc., Inc. · 1999
  • K962649Sportrol Rapid Sterility IndicatorNorth American Science Assoc., Inc. · 1997

All 6 as North American Science Assoc., Inc. →