Actuated Medical, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Actuated Medical, Inc.” (first 2012, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 214 days, against 151 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 18 |
| 2013 | 1 | 123 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 26 |
| 2017 | 0 | — |
| 2018 | 1 | 309 |
| 2019 | 0 | — |
| 2020 | 1 | 267 |
| 2021 | 0 | — |
| 2022 | 1 | 217 |
| 2023 | 1 | 186 |
| 2024 | 1 | 59 |
| 2025 | 1 | 211 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Actuated Medical, Inc. took a median 214 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 6 | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
Most recent Actuated Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 | FDS | 2025-10-31 | 211 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | FDF | 2024-10-04 | 59 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | FDF | 2023-11-03 | 186 |
| K220890 | IO Needle Safety Sheath | FMI | 2022-10-31 | 217 |
| K200646 | TubeClear System | KNT | 2020-12-04 | 267 |
| K172556 | TubeClear System | KNT | 2018-06-29 | 309 |
| K163092 | TubeClear Control Box and Clearing Stem | KNT | 2016-11-30 | 26 |
| K131052 | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) | KNT | 2013-08-16 | 123 |
| K123659 | TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) | KNT | 2012-12-20 | 22 |
| K121571 | TUBECLEAR | KNT | 2012-06-13 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Actuated Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Actuated Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03066895: BGS Neonatal Pilot Study (Completed, started 2017-11-06)
- NCT02947646: Feasibility of BabyGentleStick- Adult Pilot Study (Completed, started 2016-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Actuated Medical, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Actuated Medical, Inc.” (first 2012, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Actuated Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Actuated Medical, Inc. is 154 days. Since 2017: 214 days, versus 151 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Actuated Medical, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 6); FDF (Colonoscope And Accessories, Flexible/Rigid, 2); FDS (Gastroscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 10 Actuated Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Actuated Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.