510(k) Report

FDA applicant

Steris Corporations

Mentor, OH7 decisions2018–20210 recalls

FDA records 7 decisions for Steris Corporations (Mentor, OH) from 2018 to 2021: 7 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and MED (Sterilant, Medical Devices). Since 2016 its 510(k)s took a median of 38 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Steris Corporations’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 32019: 32021: 1
2018high 3 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Steris Corporations by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Steris Corporations’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRCIndicator, Biological Sterilization Process3decisions
  • MEDSterilant, Medical Devices2decisions
  • JOJIndicator, Physical/Chemical Sterilization Process1decision
  • ODCEndoscope Channel Accessory1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 38 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 93 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations · 20191cites it
  • K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations · 20181cites it
  • K183295Celerity HP Chemical Indicator (CI)Steris Corporations · 20191cites it
  • K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing…Steris Corporations · 20191cites it
  • K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter…Steris Corporations · 20181cites it
  • K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations · 20181cites it

What has FDA decided for it lately?

  • K203630BioGuard Air/Water and Suction ValvesSteris Corporations · 2021
  • K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing…Steris Corporations · 2019
  • K183295Celerity HP Chemical Indicator (CI)Steris Corporations · 2019
  • K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations · 2019
  • K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter…Steris Corporations · 2018
  • K180342SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations · 2018
  • K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations · 2018

All 7 as Steris Corporations →

Other applicant names beginning “Steris”

FDA records each applicant name separately; these may or may not be the same firm.

STERIS Corporation 228Steris Corparation 2Steris C/O Medical Device Consultants, Inc. 1