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Surepulse Medical Limited: FDA-registered device maker in Nottingham Nottinghamshire, United Kingdom, 1 510(k) clearance

Name: Surepulse Medical Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Surepulse Medical Limited is registered with the FDA (registration 3018685978) in Nottingham Nottinghamshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3018685978
Address: Medicity D6 Thane Road, Nottingham Nottinghamshire, United Kingdom, NG90 6BH
Owner or operator: SurePulse Medical Limited (10084383)
Roles: Exporter to the US, Specification developer
First device listed: October 18, 2022
Registered through: 2026
Brand names listed: SurePulse VS, SurePulse VS Cap

Devices it lists

Device	Product code	Class	Role	Source
Oximeter	DQA	2	Exporter to the US, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 23, 2021	K201887	VS Newborn Heart Rate Monitor	DQA	Substantially Equivalent	Surepulse Medical Limited	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 20, 2023	98292	Class III	Ongoing	Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor	Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.	accessdata.fda.gov

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Updated February 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.