Ibt Scientific
FDA Regulatory Profile
Ibt Scientific has 0 FDA recalls, 6 inspections, 1 510(k) clearance and 0 compliance actions on record.
- Latest inspection
- Dec 19, 2025 · NAI
- Latest 510(k)
- Oct 16, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 6 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Dec 19, 2025 | Creedmoor, NC | Devices | No Action Indicated (NAI) | 3029754060 |
| Dec 19, 2019 | Elkhart, IN | Devices | Voluntary Action Indicated (VAI) | 1000139989 |
| Jun 23, 2017 | Elkhart, IN | Devices | No Action Indicated (NAI) | 1000139989 |
| Mar 18, 2014 | Elkhart, IN | Devices | No Action Indicated (NAI) | 1000139989 |
| Mar 29, 2012 | Elkhart, IN | Devices | Voluntary Action Indicated (VAI) | 1000139989 |
| Aug 7, 2009 | Elkhart, IN | Devices | Voluntary Action Indicated (VAI) | 1000139989 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K263267 | Endox Test Strips | Oct 16, 2026 |