[FDAPulse](/v/fdapulse) / compare

# MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. vs Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation: FDAPulse comparison

**MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.'s review days of 276 is 1.0x Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation's 269 (95th percentile). MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. is dated 2026-10-05; Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation 2026-10-16.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. compare to Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation?

| Field | MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260005 | K260168 |
| Device | MyoVista wavECG (DG-200-B15-003) | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) |
| Applicant | HeartSciences, Inc. | Skycade Med Corporation |
| Specialty / panel | Cardiovascular | Cardiovascular |
| Product code | DPS | DQX |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-02 | 2026-01-20 |
| Decision date | 2026-10-05 | 2026-10-16 |
| Review time (days) | 276 | 269 |
| Third-party review | No | No |
| Applicant location | Southlake, TX, US | Dallas, TX, US |
| amount percentile | 95th | 93rd |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 61/100 |
| Peer rank and all 500 records (CSV) | Every comparable record ranked, with amounts, dates and scores 🔒 Click to unlock → |
| Official source URLs for every peer record | Direct links to each record at its government source 🔒 Click to unlock → |

Official records: [MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260005) · [Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260168)

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