510(k) · Cleared
ClearedEnso for Migraine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinge Health, Inc. · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Cleared on Apr 16, 2026 as substantially equivalent to K234029 (Cefaly Technology, 2024) after a 108-day review. Its family tree reaches back 7 generations to 2014.
- Decided
- Apr 16, 2026
- Review
- 108 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN120019 (2014). No later device cites it as a predicate yet.
- Root · 7 generations backDEN120019 CefalyStx-Med Sprl · 2014
- 6 generations backK160237 CefalyCefaly Technology · 2016
- 5 generations backK171446 Cefaly AcuteCefaly Technology · 2017
- 4 generations backK173006 Cefaly DualCefaly Technology · 2017
- 3 generations backK201895 Cefaly DualCefaly Technology · 2020
- 2 generations backK212071 Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID…Cefaly Technology · 2022
- 1 generation backK234029 CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 2024
- This deviceK254216 Enso for MigraineHinge Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| −6 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| −5 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| −4 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| −3 | K201895 | Cefaly Dual | Cefaly Technology | 2020 | — |
| −2 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx… | Cefaly Technology | 2022 | — |
| −1 | K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024 | — |
| 0 (this device) | K254216 | Enso for Migraine | Hinge Health, Inc. | 2026 | — |
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 PCC? 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 PCC device
- #1 K201895 Cefaly Dualscore 16.0 · 4 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 |
|---|---|---|---|
| * | K234029 | CEFALY Connected - OTC, CEFALY Connected - RxSummary page 5…Transcutaneous electrical nerve stimulator to treat headache Product Code PCC Panel Neurology Proposed Predicate K234029 Device CEFALY Connected – OTC 21 CFR 882.5891, PCC, Class II Device Descri… | 2024 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All PCC devicesPCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PCC
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PCC
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCC
No recall names PCC since 2007.
Adverse event reports per year · PCC
2in 2025
MAUDE reports naming product code PCC, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | 88 | 0 | 7 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 5 | 211 | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Enso for Migraine is indicated for patients 18 years of age or older for acute treatment of migraine with or without aura
and preventative treatment of migraine.
Enso for Migraine is for patients diagnosed with migraine by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254216: Enso for Migraine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254216
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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