510(k) Report

FDA applicant

Actuated Medical, Inc.

Bellefonte, PA10 decisions2012–20250 recalls

FDA records 10 decisions for Actuated Medical, Inc. (Bellefonte, PA) from 2012 to 2025: 10 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and FDF (Colonoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 214 days from receipt to decision, against 169 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 9 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 Actuated Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 22013: 12016: 12018: 12020: 12022: 12023: 12024: 12025: 1
2012high 2 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Actuated Medical, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Actuated Medical, 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?

  • KNTTubes, Gastrointestinal (And Accessories)6decisions
  • FDFColonoscope And Accessories, Flexible/Rigid2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision
  • FDSGastroscope And Accessories, Flexible/Rigid1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 214 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 169 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 9 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.

  • K121571TubeclearActuated Medical, Inc. · 20123cite it
  • K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. · 20162cite it
  • K131052Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 20132cite it
  • K231254GripTract-GI Endoscopic Tissue ManipulatorActuated Medical, Inc. · 20231cites it
  • K123659Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)Actuated Medical, Inc. · 20121cites it
  • K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsActuated Medical, Inc. · 20241cites it

What has FDA decided for it lately?

  • K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc. · 2025
  • K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsActuated Medical, Inc. · 2024
  • K231254GripTract-GI Endoscopic Tissue ManipulatorActuated Medical, Inc. · 2023
  • K220890IO Needle Safety SheathActuated Medical, Inc. · 2022
  • K200646TubeClear SystemActuated Medical, Inc. · 2020
  • K172556TubeClear SystemActuated Medical, Inc. · 2018
  • K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016
  • K131052Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013

All 10 as Actuated Medical, Inc. →