510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Surepulse Medical Limited

Nottingham Nottinghamshire, GB

SUREPULSE MEDICAL LIMITED appears in FDA device records in Nottingham Nottinghamshire, GB. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
5
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Surepulse Medical Limited in 2021.

Clearances by year, as a table
510(k) clearance decisions for Surepulse Medical Limited, by decision year
YearClearances
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K201887VS Newborn Heart Rate MonitorDQASubstantially Equivalent

Registered establishments

FDA registered establishments for Surepulse Medical Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30186859783018685978SUREPULSE MEDICAL LIMITEDMedicity D6 Thane Road, Nottingham Nottinghamshire NG90 6BH GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1360-2026Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.Class IIIOpen, Classified
Z-1359-2026Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.Class IIIOpen, Classified
Z-1358-2026Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.Class IIIOpen, Classified
Z-1357-2026Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.Class IIIOpen, Classified
Z-1356-2026Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.Class IIIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain