Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.
Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc. (Massachusetts): 510(k) cleared for Elucid Bioimaging, Inc. Its amount of 106 is below the median of 138 (38th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, 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: 106 · 38th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262015 |
| Device | Elucid FFR-IQ (B.1) |
| Applicant | Elucid Bioimaging, Inc. |
| Specialty / panel | Cardiovascular |
| Product code | PJA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-15 |
| Decision date | 2026-09-29 |
| Review time (days) | 106 |
| Third-party review | No |
| Applicant location | Boston, MA, US |
| amount percentile | 38th of 414 (median 138, 0.8x median) |
| Peer records CSV (41 MA 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: 2026-09-29
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MA first): GSPE Spacer (K260063) · Sensinel Cardiopulmonary Management (CPM) System (K260801) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.'s amount: 38th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 106-day review: this device is a strong predicate for similar products.
- Posted 36 days ago.
What is the FDAPulse record for Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc. in Massachusetts?
Elucid FFR-IQ (B.1) (K262015) by Elucid Bioimaging, Inc. was cleared on 2026-09-29 after 106 days of review.
How does Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc. compare to other Massachusetts FDAPulse records?
Its amount of 106 is below the median (38th percentile); smaller records often move faster and face less competition. It is 36 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Elucid FFR-IQ (B.1) (K262015) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Elucid FFR-IQ (B.1) (K262015) | MA | 2026-09-29 |
| 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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