Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Actuated Medical, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
186 daysmedian FDA review time
309 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model G | Actuated Medical, Inc. | 2025-10-31 | 211 | 0 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024-10-04 | 59 | 0 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023-11-03 | 186 | 0 |
| K220890 | IO Needle Safety Sheath | Actuated Medical, Inc. | 2022-10-31 | 217 | 0 |
| K200646 | TubeClear System | Actuated Medical, Inc. | 2020-12-04 | 267 | 0 |
| K172556 | TubeClear System | Actuated Medical, Inc. | 2018-06-29 | 309 | 0 |
| K163092 | TubeClear Control Box and Clearing Stem | Actuated Medical, Inc. | 2016-11-30 | 26 | 0 |
| K131052 | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) | Actuated Medical, Inc. | 2013-08-16 | 123 | 0 |
| K123659 | TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING S | Actuated Medical, Inc. | 2012-12-20 | 22 | 0 |
| K121571 | TUBECLEAR | Actuated Medical, Inc. | 2012-06-13 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda