Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. (Iowa): 510(k) cleared for CIVCO Medical Instruments Co., Inc. Its amount of 253 is above the median of 138 (80th percentile). Dated 42 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: 253 · 80th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related IA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260114 |
| Device | Align® Cover and Pad Guidance Tool |
| Applicant | CIVCO Medical Instruments Co., Inc. |
| Specialty / panel | Radiology |
| Product code | ITX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-14 |
| Decision date | 2026-09-24 |
| Review time (days) | 253 |
| Third-party review | No |
| Applicant location | Coralville, IA, US |
| amount percentile | 80th of 414 (median 138, 1.8x median) |
| Peer records CSV (2 IA 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: 2026-09-24
- 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: Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. and 2 Iowa peers
- Iowa FDAPulse records like this one: 2
- Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.'s amount: 80th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Iowa peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 253-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 42 days ago.
What is the FDAPulse record for Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. in Iowa?
Align® Cover and Pad Guidance Tool (K260114) by CIVCO Medical Instruments Co., Inc. was cleared on 2026-09-24 after 253 days of review.
How does Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. compare to other Iowa FDAPulse records?
Its amount of 253 sits in the upper half (80th percentile) of 414 records; the median is 138. It is 42 days old, still within a typical 45-day follow-up window.
Align® Cover and Pad Guidance Tool (K260114) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Align® Cover and Pad Guidance Tool (K260114) | IA | 2026-09-24 | This record |
| VenusCT (K260510) | CA | 2026-10-19 | View record → |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 | Compare Align® Cover and Pad Guidance Tool (K260114) vs AVIEW Aorta Metrics (K260391) → |
| Vista AI Scan (K260092) | CA | 2026-10-07 | View record → |
Compare Align® Cover and Pad Guidance Tool (K260114) vs OOOPDS (K254214) →
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