SUREPULSE MEDICAL LTD
FDA Regulatory Profile
SUREPULSE MEDICAL LTD has 5 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.
- Latest recall
- Z-1359-2026 · Class III · Jan 20, 2023
- Latest inspection
- Aug 1, 2024 · OAI
- Latest 510(k)
- Jul 23, 2021
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 1 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 1 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1359-2026 | Class III | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor | Jan 20, 2023 |
| Z-1356-2026 | Class III | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor | Jan 20, 2023 |
| Z-1360-2026 | Class III | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor | Jan 20, 2023 |
| Z-1358-2026 | Class III | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor | Jan 20, 2023 |
| Z-1357-2026 | Class III | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor | Jan 20, 2023 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 1, 2024 | Nottingham, United Kingdom | Devices | Official Action Indicated (OAI) | 3018685978 |
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 |
|---|
| K201887 | VS Newborn Heart Rate Monitor | Jul 23, 2021 |