Restrata (K261245): 510(k) cleared for Acera Surgical, Inc.
Restrata (K261245): 510(k) cleared for Acera Surgical, Inc. (Missouri): 510(k) cleared for Acera Surgical, Inc. Its amount of 183 is above the median of 138 (64th percentile). Dated 19 days ago, it is in the active follow-up window. Score 48/100. 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: 183 · 64th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related MO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261245 |
| Device | Restrata |
| Applicant | Acera Surgical, Inc. |
| Specialty / panel | Other |
| Product code | QSZ |
| Device class | U |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-10-16 |
| Review time (days) | 183 |
| Third-party review | No |
| Applicant location | St. Louis, MO, US |
| amount percentile | 64th of 414 (median 138, 1.3x median) |
| Peer records CSV (4 MO 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: 2026-10-16
- 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: Restrata (K261245): 510(k) cleared for Acera Surgical, Inc. and 4 Missouri peers
- Missouri FDAPulse records like this one: 4
- Restrata (K261245): 510(k) cleared for Acera Surgical, Inc.'s amount: 64th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Missouri peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 183-day review, longer than typical.
- Posted 19 days ago.
What is the FDAPulse record for Restrata (K261245): 510(k) cleared for Acera Surgical, Inc. in Missouri?
Restrata (K261245) by Acera Surgical, Inc. was cleared on 2026-10-16 after 183 days of review.
How does Restrata (K261245): 510(k) cleared for Acera Surgical, Inc. compare to other Missouri FDAPulse records?
Its amount of 183 sits in the upper half (64th percentile) of 414 records; the median is 138. It is 19 days old, still within a typical 45-day follow-up window.
Restrata (K261245) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Restrata (K261245) | MO | 2026-10-16 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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