510(k) Report

FDA applicant

Clear Guide Medical

Baltimore, MD6 decisions2014–20240 recalls

FDA records 6 decisions for Clear Guide Medical (Baltimore, MD) from 2014 to 2024: 6 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2014: 12016: 12017: 12020: 22024: 1
2014high 2 (2020) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Clear Guide Medical’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?

  • JAKSystem, X-Ray, Tomography, Computed5decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 112 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K141806Clear Guide OneClear Guide Medical · 20142cite it
  • K171677Clear Guide SCENERGYClear Guide Medical · 20172cite it
  • K153004Clear Guide SCENERGYClear Guide Medical · 20161cites it
  • K201188Clear Guide SCENERGYClear Guide Medical · 20201cites it

What has FDA decided for it lately?

  • K234030Clear Guide SCENERGYClear Guide Medical · 2024
  • K201188Clear Guide SCENERGYClear Guide Medical · 2020
  • K201898Clear Guide SCENERGYClear Guide Medical · 2020
  • K171677Clear Guide SCENERGYClear Guide Medical · 2017
  • K153004Clear Guide SCENERGYClear Guide Medical · 2016
  • K141806Clear Guide OneClear Guide Medical · 2014

All 6 as Clear Guide Medical →

Other applicant names beginning “Clear”

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

Clear Choice Therapeutics 2Clear Future, Inc. 1Clear Window Industrial, Ltd. 1Clear Moves Aligners 1Clear Corp. 1Clear-Tone Hearing Aid Center 1Clear Catheter Systems 1