Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC
Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC (Illinois): 510(k) cleared for Ecomed Solutions, LLC. Its amount of 266 is above the median of 138 (86th percentile). Dated 54 days ago, it serves as a historical benchmark. Score 60/100. 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: 266 · 86th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254123 |
| Device | Ecomed Disposable Administration Sets |
| Applicant | Ecomed Solutions, LLC |
| Specialty / panel | General Hospital |
| Product code | FPA |
| Device class | 2 |
| Clearance type | Abbreviated |
| Decision | Substantially Equivalent |
| Received | 2025-12-19 |
| Decision date | 2026-09-11 |
| Review time (days) | 266 |
| Third-party review | No |
| Applicant location | Lindenhurst, IL, US |
| amount percentile | 86th of 414 (median 138, 1.9x median) |
| Peer records CSV (57 IL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-11
- 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: Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC's amount: 86th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 266-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Abbreviated 510(k): a modification of an existing device.
What is the FDAPulse record for Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC in Illinois?
Ecomed Disposable Administration Sets (K254123) by Ecomed Solutions, LLC was cleared on 2026-09-11 after 266 days of review.
How does Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC compare to other Illinois FDAPulse records?
Its amount of 266 sits in the upper half (86th percentile) of 414 records; the median is 138. It is 54 days old; check the official source for later updates before acting.
Ecomed Disposable Administration Sets (K254123) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ecomed Disposable Administration Sets (K254123) | IL | 2026-09-11 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
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