iOS CamAPS FX (K261896): 510(k) cleared for CamDiab
iOS CamAPS FX (K261896): 510(k) cleared for CamDiab: 510(k) cleared for CamDiab. Its amount of 100 is below the median of 138 (35th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 100 · 35th percentile of 414 FDAPulse records · 0.7x 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 | K261896 |
| Device | iOS CamAPS FX |
| Applicant | CamDiab |
| Specialty / panel | Clinical Chemistry |
| Product code | QJI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-08 |
| Decision date | 2026-09-16 |
| Review time (days) | 100 |
| Third-party review | No |
| Applicant location | London, GB |
| amount percentile | 35th of 414 (median 138, 0.7x 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: 2026-09-16
- 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: iOS CamAPS FX (K261896): 510(k) cleared for CamDiab and 8 GB peers
- GB FDAPulse records like this one: 8
- iOS CamAPS FX (K261896): 510(k) cleared for CamDiab's amount: 35th 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)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 100-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for iOS CamAPS FX (K261896): 510(k) cleared for CamDiab?
iOS CamAPS FX (K261896) by CamDiab was cleared on 2026-09-16 after 100 days of review.
How does iOS CamAPS FX (K261896): 510(k) cleared for CamDiab compare to other FDAPulse records?
Its amount of 100 is below the median (35th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
iOS CamAPS FX (K261896) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| iOS CamAPS FX (K261896) | GB | 2026-09-16 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Clinical Chemistry devices
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