FDAPulse / report
STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.
STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.: 510(k) cleared for Rhythm AI, Ltd. Its amount of 29 is below the median of 138 (7th percentile). Dated 12 days ago, it is in the active follow-up window. Score 47/100. 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: 29 · 7th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 7 related GB FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263380 |
| Device | STAR Apollo Mapping System |
| Applicant | Rhythm AI, Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | DQK |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-24 |
| Decision date | 2026-10-23 |
| Review time (days) | 29 |
| Third-party review | No |
| Applicant location | London, GB |
| amount percentile | 7th of 414 (median 138, 0.2x median) |
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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: 2026-10-23
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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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: STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd. and 8 GB peers
- GB FDAPulse records like this one: 8
- STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.'s amount: 7th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every GB peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 29-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 12 days ago.
What is the FDAPulse record for STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd.?
STAR Apollo Mapping System (K263380) by Rhythm AI, Ltd. was cleared on 2026-10-23 after 29 days of review.
How does STAR Apollo Mapping System (K263380): 510(k) cleared for Rhythm AI, Ltd. compare to other FDAPulse records?
Its amount of 29 is below the median (7th percentile); smaller records often move faster and face less competition. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
STAR Apollo Mapping System (K263380) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| STAR Apollo Mapping System (K263380) | GB | 2026-10-23 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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