MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. (Texas): 510(k) cleared for HeartSciences, Inc. Its amount of 276 is top-decile (95th percentile of 414 records). Dated 30 days ago, it is in the active follow-up window. Score 61/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 276 · 95th percentile of 414 FDAPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260005 |
| Device | MyoVista wavECG (DG-200-B15-003) |
| Applicant | HeartSciences, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | DPS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-02 |
| Decision date | 2026-10-05 |
| Review time (days) | 276 |
| Third-party review | No |
| Applicant location | Southlake, TX, US |
| amount percentile | 95th of 414 (median 138, 2.0x median) |
| Peer records CSV (12 TX records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-05
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (TX first): Small Diameter Core Wire (CMAN-000-00); Small Diameter Core · Kinetic Software Library (K260640) · SmartRead(TM) Medical Device Identifier (4100) (DEN260007) · DASH Flu A/B Test (K261347) · Ntegrate Threaded Nail System (K261961) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. and 12 Texas peers
- Texas FDAPulse records like this one: 12
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.'s amount: 95th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 276-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 30 days ago.
What is the FDAPulse record for MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. in Texas?
MyoVista wavECG (DG-200-B15-003) (K260005) by HeartSciences, Inc. was cleared on 2026-10-05 after 276 days of review.
How does MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc. compare to other Texas FDAPulse records?
This is a top-decile record: its amount of 276 is 2.0x the median of 138 across 414 records. It is 30 days old, still within a typical 45-day follow-up window.
MyoVista wavECG (DG-200-B15-003) (K260005) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| MyoVista wavECG (DG-200-B15-003) (K260005) | TX | 2026-10-05 | This record |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 | View record → |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 | View record → |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 | Compare MyoVista wavECG (DG-200-B15-003) (K260005) vs Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) → |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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