ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH
ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH (Delaware): 510(k) cleared for Heidelberg Engineering GmbH. Its amount of 168 is above the median of 138 (61st percentile). Dated 54 days ago, it serves as a historical benchmark. Score 42/100. 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: 168 · 61th percentile of 414 FDAPulse records · 1.2x 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 | K261019 |
| Device | ANTERION |
| Applicant | Heidelberg Engineering GmbH |
| Specialty / panel | Ophthalmic |
| Product code | OBO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-27 |
| Decision date | 2026-09-11 |
| Review time (days) | 168 |
| Third-party review | No |
| Applicant location | Heidelberg, DE |
| amount percentile | 61th of 414 (median 138, 1.2x median) |
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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: ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH's amount: 61st 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)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 168-day review, longer than typical.
What is the FDAPulse record for ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH in Delaware?
ANTERION (K261019) by Heidelberg Engineering GmbH was cleared on 2026-09-11 after 168 days of review.
How does ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH compare to other Delaware FDAPulse records?
Its amount of 168 sits in the upper half (61th percentile) of 414 records; the median is 138. It is 54 days old; check the official source for later updates before acting.
ANTERION (K261019) vs. top 3 peers
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