# Actuated Medical, Inc.

- Location (FDA's records): Bellefonte, PA
- FDA decisions: 10 (2012–2025): 10 510(k) clearances
- Product codes: KNT (6), FDF (2), FMI (1), FDS (1)
- 510(k) review time since 2016: median 214 days, against 169 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 11 (9 its own); citations of its devices by later devices: 10 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.): 1 (https://510kreport.com/company/arrow-international-subsidiary-of-teleflex)
- Nova Design Technologies, Ltd.: 1 (https://510kreport.com/company/nova-design-technologies)

## Firms that cite its devices most
- Bionix Development Corp.: 1 (https://510kreport.com/company/bionix-development)

## Its most-cited devices
- K121571: Tubeclear (2012), cited by 3
- K163092: TubeClear Control Box and Clearing Stem (2016), cited by 2
- K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models) (2013), cited by 2
- K231254: GripTract-GI Endoscopic Tissue Manipulator (2023), cited by 1
- K123659: Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear) (2012), cited by 1
- K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (2024), cited by 1

## Recent decisions
- K251041: GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (Oct 31, 2025)
- K242325: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (Oct 4, 2024)
- K231254: GripTract-GI Endoscopic Tissue Manipulator (Nov 3, 2023)
- K220890: IO Needle Safety Sheath (Oct 31, 2022)
- K200646: TubeClear System (Dec 4, 2020)
- K172556: TubeClear System (Jun 29, 2018)
- K163092: TubeClear Control Box and Clearing Stem (Nov 30, 2016)
- K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models) (Aug 16, 2013)

Source page: https://510kreport.com/company/actuated-medical