Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.
Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. (Delaware): 510(k) cleared for Whiteley USA, Inc. Its amount of 301 is top-decile (96th percentile of 414 records). Dated 19 days ago, it is in the active follow-up window. Score 61/100. 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: 301 · 96th percentile of 414 FDAPulse records · 2.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254094 |
| Device | Endox High Level Disinfectant |
| Applicant | Whiteley USA, Inc. |
| Specialty / panel | General Hospital |
| Product code | MED |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-19 |
| Decision date | 2026-10-16 |
| Review time (days) | 301 |
| Third-party review | No |
| Applicant location | Wilmington, DE, US |
| amount percentile | 96th of 414 (median 138, 2.2x median) |
| Peer records CSV (25 DE 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: 2026-10-16
- 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: Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.'s amount: 96th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 301-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 19 days ago.
What is the FDAPulse record for Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. in Delaware?
Endox High Level Disinfectant (K254094) by Whiteley USA, Inc. was cleared on 2026-10-16 after 301 days of review.
How does Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc. compare to other Delaware FDAPulse records?
This is a top-decile record: its amount of 301 is 2.2x the median of 138 across 414 records. It is 19 days old, still within a typical 45-day follow-up window.
Endox High Level Disinfectant (K254094) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) | PA | 2026-10-09 |
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