Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation
Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation (Wisconsin): 510(k) cleared for Epic Systems Corporation. Its amount of 259 is above the median of 138 (82nd percentile). Dated 48 days ago, it serves as a historical benchmark. Score 55/100. 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: 259 · 82th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related WI FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260008 |
| Device | Deterioration Index Version 2 |
| Applicant | Epic Systems Corporation |
| Specialty / panel | Cardiovascular |
| Product code | QNL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-02 |
| Decision date | 2026-09-18 |
| Review time (days) | 259 |
| Third-party review | No |
| Applicant location | Verona, WI, US |
| amount percentile | 82th of 414 (median 138, 1.9x median) |
| Peer records CSV (4 WI 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: 2026-09-18
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation and 4 Wisconsin peers
- Wisconsin FDAPulse records like this one: 4
- Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation's amount: 82nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 259-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation in Wisconsin?
Deterioration Index Version 2 (K260008) by Epic Systems Corporation was cleared on 2026-09-18 after 259 days of review.
How does Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation compare to other Wisconsin FDAPulse records?
Its amount of 259 sits in the upper half (82th percentile) of 414 records; the median is 138. It is 48 days old; check the official source for later updates before acting.
Deterioration Index Version 2 (K260008) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Deterioration Index Version 2 (K260008) | WI | 2026-09-18 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
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