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Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. vs AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.: FDAPulse comparison
Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.'s review days of 253 is 1.0x AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.'s 252 (80th percentile). Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. is dated 2026-09-24; AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd. 2026-10-16.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. compare to AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.?
| Field | Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. | AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K260114 | K260391 |
| Device | Align® Cover and Pad Guidance Tool | AVIEW Aorta Metrics |
| Applicant | CIVCO Medical Instruments Co., Inc. | Coreline Soft Co., Ltd. |
| Specialty / panel | Radiology | Radiology |
| Product code | ITX | JAK |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-01-14 | 2026-02-06 |
| Decision date | 2026-09-24 | 2026-10-16 |
| Review time (days) | 253 | 252 |
| Third-party review | No | No |
| Applicant location | Coralville, IA, US | Seoul, KR |
| amount percentile | 80th | 80th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc. · AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
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