VS Newborn Heart Rate Monitor— 510(k) K201887
Substantially EquivalentSurepulse Medical Limited
FDA 510(k) clearance K201887 for VS Newborn Heart Rate Monitor, Substantially Equivalent on 2021-07-23. Applicant: Surepulse Medical Limited. Device class: 2.
Clearance details
- Applicant
- Surepulse Medical Limited
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nottingham, GB
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
Adverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201887
K-number listed on FDA's recall record- Z-1356-2026 — Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
- Z-1357-2026 — Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
- Z-1358-2026 — Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
- Z-1359-2026 — Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
- Z-1360-2026 — Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201887.
Data sourced from openFDA. This site is unofficial and independent of the FDA.