510(k) Report

FDA applicant

Medivators, Inc.

Minneapolis, MN13 decisions1987–20232 recalls

FDA records 13 decisions for Medivators, Inc. (Minneapolis, MN) from 1987 to 2023: 13 510(k) clearances. Most are in product codes FEB (Accessories, Cleaning, For Endoscope) and OCX (Endoscopic Irrigation/Suction System). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Medivators”.

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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2014: 22015: 12016: 32017: 12022: 12023: 2
2007high 3 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2010: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medivators, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medivators, 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?

  • FEBAccessories, Cleaning, For Endoscope4decisions
  • OCXEndoscopic Irrigation/Suction System2decisions
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • NIHDisinfectant, Subsystem, Water Purification1decision
  • NVEWasher, Cleaner, Automated, Endoscope1decision
  • JOJIndicator, Physical/Chemical Sterilization Process1decision

Also: KTI (1), MED (1), FAJ (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 138 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 1 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.

  • K914145DSD-91(TM) Disinfector for Flexible EndoscopesMedivators, Inc. · 19945cite it
  • K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 20162cite it
  • K993042Medivators 5 Minute High-Level DisinfectantMedivators, Inc. · 20002cite it
  • K140753Endo Smart Bottle, Rinse and Insufflation SystemMedivators · 20141cites it
  • K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. · 20161cites it

What has FDA decided for it lately?

  • K231418ENDOGATOR™ Hybrid Irrigation TubingMedivators · 2023
  • K223040Endo SmartCapMedivators, Inc. · 2023
  • K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc. · 2022
  • K172677Advantage Plus Pass-ThruMedivators, Inc. · 20171 recall
  • K162128Scope Buddy Plus Endoscope Flushing AidMedivators, Inc. · 2016
  • K160846AmplifEYEMedivators, Inc. · 2016
  • K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc. · 2016
  • K151522DEFENDO Bronchoscopy Suction ValveMedivators, Inc. · 2015

All 11 as Medivators, Inc. →All 2 as Medivators →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K082988Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru…Nov 13, 2023Class II
  • K914145DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup…Jun 15, 2010

Other applicant names beginning “Medivators”

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

Medivators (A Subsidiary of Steris Corporation) 3Medivators Reprocessing Systems 3