510(k) Report

FDA applicant

Surepulse Medical Limited

Nottingham, GB1 decision2021–20215 recalls

FDA records 1 decision for Surepulse Medical Limited (Nottingham, GB) in 2021: 1 510(k) clearance. All are in product code DQA (Oximeter). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Surepulse Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

5in 2023

2023: 5
2021high 5 (2023) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Surepulse Medical Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surepulse Medical Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQAOximeter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K201887VS Newborn Heart Rate MonitorSurepulse Medical Limited · 20215 recalls

The one decision as Surepulse Medical Limited →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K201887Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorJan 20, 2023Class III
  • K201887Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorJan 20, 2023Class III
  • K201887Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorJan 20, 2023Class III
  • K201887Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorJan 20, 2023Class III
  • K201887Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorJan 20, 2023Class III