510(k) · Cleared
ClearedRADIFOCUS Torque Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Products (Hangzhou) Co., Ltd. · MOF Guide, Wire, Catheter, Neurovasculature
Cleared on Jun 29, 2022 as substantially equivalent to K910969 (Terumo Corp., 1991) after a 90-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 29, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- MOF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910969 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910969 Torque Device for a Guide WireTerumo Corp. · 1991
- This deviceK220934 RADIFOCUS Torque DeviceTerumo Medical Products (Hangzhou) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910969 | Torque Device for a Guide Wire | Terumo Corp. | 1991 | — |
| 0 (this device) | K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOF device
- #1 K253168 0.014” Willow Guidewirescore 17.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910969 | Torque Device for a Guide WireSummary page 5…y: PTL Classification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: K910969 – TORQUE DEVICE FOR A GUIDE WIRE, manufactured by Terumo Corporation, Japan. D. DEVICE DESCRIPTION (807.92(a)(4)) RA… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K910969.
How does its category compare?
All MOF devicesMOF Guide, Wire, Catheter, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MOF
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MOF
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOF
No recall names MOF since 2007.
Adverse event reports per year · MOF
135in 2025
MAUDE reports naming product code MOF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 133 | 0 | 5 |
| 2016 | 4 | 61 | 0 | 3 |
| 2017 | 1 | — | 0 | 15 |
| 2018 | 2 | — | 0 | 11 |
| 2019 | 4 | 58 | 0 | 12 |
| 2020 | 4 | 36 | 0 | 18 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 92 |
| 2023 | 4 | 199 | 0 | 91 |
| 2024 | 2 | — | 0 | 95 |
| 2025 | 5 | 172 | 0 | 135 |
| 2026 | 11 | 192 | 0 | — |
What is it indicated for?
RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220934: RADIFOCUS Torque Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220934
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026