510(k) Report

FDA applicant

Medivators (A Subsidiary of Steris Corporation)

Conroe, TX3 decisions2023–20240 recalls

FDA records 3 decisions for Medivators (A Subsidiary of Steris Corporation) (Conroe, TX) from 2023 to 2024: 3 510(k) clearances. All are in product code ODC (Endoscope Channel Accessory). Since 2016 its 510(k)s took a median of 244 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 14 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, gastroenterology and urology panel, where it files most

How often FDA has decided Medivators (A Subsidiary of Steris Corporation)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2023: 12024: 2
2023high 2 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Medivators (A Subsidiary of Steris Corporation) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medivators (A Subsidiary of Steris…’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?

  • ODCEndoscope Channel Accessory3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 244 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo…Medivators (A Subsidiary of Steris Corporation) · 20232cite it

What has FDA decided for it lately?

  • K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve…Medivators (A Subsidiary of Steris Corporation) · 2024
  • K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use…Medivators (A Subsidiary of Steris Corporation) · 2024
  • K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo…Medivators (A Subsidiary of Steris Corporation) · 2023

All 3 as Medivators (A Subsidiary of Steris Corporation) →

Other applicant names beginning “Medivators”

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

Medivators, Inc. 13Medivators Reprocessing Systems 3