510(k) Report

FDA applicant

Sterilucent, Inc.

Minneapolis, MN7 decisions2014–20190 recalls

FDA records 7 decisions for Sterilucent, Inc. (Minneapolis, MN) from 2014 to 2019: 7 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and MLR (Sterilizer, Chemical). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 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 Sterilucent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2019

2014: 32015: 12019: 3
2014high 3 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Sterilucent, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sterilucent, 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?

  • FRCIndicator, Biological Sterilization Process3decisions
  • MLRSterilizer, Chemical2decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision
  • JOJIndicator, Physical/Chemical Sterilization Process1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K140464Sterilucent PSD-85 Hydrogen Peroxide SterilizerSterilucent, Inc. · 20142cite it
  • K141312Sterilucent Process Challenge DeviceSterilucent, Inc. · 20141cites it
  • K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device…Sterilucent, Inc. · 20191cites it

What has FDA decided for it lately?

  • K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device…Sterilucent, Inc. · 2019
  • K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc. · 2019
  • K190005Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc. · 2019
  • K142109Sterilucent Sterilization Container SystemSterilucent, Inc. · 2015
  • K141238Sterilucent Self-Contained Biological IndicatorSterilucent, Inc. · 2014
  • K141312Sterilucent Process Challenge DeviceSterilucent, Inc. · 2014
  • K140464Sterilucent PSD-85 Hydrogen Peroxide SterilizerSterilucent, Inc. · 2014

All 7 as Sterilucent, Inc. →