Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH
Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH (Delaware): 510(k) cleared for ACTO GmbH. Its amount of 273 is top-decile (95th percentile of 414 records). Dated 44 days ago, it serves as a historical benchmark. 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: 273 · 95th percentile of 414 FDAPulse records · 2.0x 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 | K254168 |
| Device | Actolind® (06.3637. Actolind® Gel Plus) |
| Applicant | ACTO GmbH |
| Specialty / panel | Other |
| Product code | FRO |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-22 |
| Review time (days) | 273 |
| Third-party review | No |
| Applicant location | Braunschweig, DE |
| amount percentile | 95th of 414 (median 138, 2.0x median) |
| Peer records CSV (25 DE 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: 2026-09-22
- Data refreshed: 2026-11-04
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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: Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH's amount: 95th percentile of 414 records
- Timing: Low: older than 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 273-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 44 days ago.
What is the FDAPulse record for Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH in Delaware?
Actolind® (06.3637. Actolind® Gel Plus) (K254168) by ACTO GmbH was cleared on 2026-09-22 after 273 days of review.
How does Actolind® (06.3637. Actolind® Gel Plus) (K254168): 510(k) cleared for ACTO GmbH compare to other Delaware FDAPulse records?
This is a top-decile record: its amount of 273 is 2.0x the median of 138 across 414 records. It is 44 days old, still within a typical 45-day follow-up window.
Actolind® (06.3637. Actolind® Gel Plus) (K254168) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Actolind® (06.3637. Actolind® Gel Plus) (K254168) | DE | 2026-09-22 |
| THERMEO® I MSI (K260031) | DE | 2026-09-29 |
| CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) | DE | 2026-09-15 |
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