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Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation vs Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.: FDAPulse comparison

Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation's review days of 269 is 1.1x Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.'s 238 (93rd percentile). Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation is dated 2026-10-16; Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc. 2026-10-23.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation compare to Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.?

FieldSmall Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med CorporationKinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK260168K260640
DeviceSmall Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Kinetic Software Library
ApplicantSkycade Med CorporationMonebo Technologies, Inc.
Specialty / panelCardiovascularCardiovascular
Product codeDQXDPS
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-202026-02-27
Decision date2026-10-162026-10-23
Review time (days)269238
Third-party reviewNoNo
Applicant locationDallas, TX, USAustin, TX, US
amount percentile93rd76th
Predicate Speed & CAPA Advisory Opportunity Score61/10054/100
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Official records: Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation · Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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