CADDIE (K260133): 510(k) cleared for Odin Medical Limited
CADDIE (K260133): 510(k) cleared for Odin Medical Limited: 510(k) cleared for Odin Medical Limited. Its amount of 239 is above the median of 138 (77th percentile). Dated 53 days ago, it serves as a historical benchmark. Score 47/100. 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: 239 · 77th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 7 related GB FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260133 |
| Device | CADDIE |
| Applicant | Odin Medical Limited |
| Specialty / panel | Gastroenterology, Urology |
| Product code | QNP |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-01-16 |
| Decision date | 2026-09-12 |
| Review time (days) | 239 |
| Third-party review | No |
| Applicant location | London, GB |
| amount percentile | 77th of 414 (median 138, 1.7x 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: 2026-09-12
- 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: CADDIE (K260133): 510(k) cleared for Odin Medical Limited and 8 GB peers
- GB FDAPulse records like this one: 8
- CADDIE (K260133): 510(k) cleared for Odin Medical Limited's amount: 77th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every GB peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 239-day review, longer than typical.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for CADDIE (K260133): 510(k) cleared for Odin Medical Limited?
CADDIE (K260133) by Odin Medical Limited was cleared on 2026-09-12 after 239 days of review.
How does CADDIE (K260133): 510(k) cleared for Odin Medical Limited compare to other FDAPulse records?
Its amount of 239 sits in the upper half (77th percentile) of 414 records; the median is 138. It is 53 days old; check the official source for later updates before acting.
CADDIE (K260133) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CADDIE (K260133) | GB | 2026-09-12 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
Related records
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- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Gastroenterology & Urology devices
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