Class Class II

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048)

K251048 2025-05-02 Special
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Description

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 by STERIS Corporation, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251048
Clearance Date2025-05-02
Clearance TypeSpecial
Product CodeJOJ
Regulation Number880.2800

Categories

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Predicate lineage for K251048

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K152394Rapicide PA High-Level Disinfectant Test StripsMedivators, Inc.2016

Trace the full predicate network for K251048

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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