510(k) Report

FDA applicant

OTU Medical, Inc.

San Jose, CA5 decisions2018–20230 recalls

FDA records 5 decisions for OTU Medical, Inc. (San Jose, CA) from 2018 to 2023: 5 510(k) clearances. Most are in product codes FAJ (Cystoscope And Accessories, Flexible/Rigid) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 125 days from receipt to decision, against 191 for FDA’s reviews in the same codes and years. Its devices cite 6 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, gastroenterology and urology panel, where it files most

How often FDA has decided OTU Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12021: 12022: 22023: 1
2018high 2 (2022) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like OTU Medical, Inc.’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?

  • FAJCystoscope And Accessories, Flexible/Rigid2decisions
  • FGBUreteroscope And Accessories, Flexible/Rigid2decisions
  • EOQBronchoscope (Flexible Or Rigid)1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 125 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 191 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K181977WiScope Digital Endoscope SystemOTU Medical, Inc. · 20182cite it
  • K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image…OTU Medical, Inc. · 20211cites it
  • K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemOTU Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K231702WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical TabletOTU Medical, Inc. · 2023
  • K220399WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image SystemOTU Medical, Inc. · 2022
  • K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image SystemOTU Medical, Inc. · 2022
  • K210579WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image…OTU Medical, Inc. · 2021
  • K181977WiScope Digital Endoscope SystemOTU Medical, Inc. · 2018

All 5 as OTU Medical, Inc. →