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Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. vs DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies: FDAPulse comparison

Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.'s review days of 352 is 1.2x DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies's 282 (97th percentile). Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. is dated 2026-09-18; DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies 2026-09-25.

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

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How does Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. compare to DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies?

FieldTriever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc.DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
Record510(k) clearance510(k) clearance
510(k) numberK253419K254058
DeviceTriever Duo CatheterDistaSense(TM) (v1)
ApplicantInari Medical, Inc.Life Detection Technologies
Specialty / panelCardiovascularCardiovascular
Product codeQEWDRT
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-10-012025-12-17
Decision date2026-09-182026-09-25
Review time (days)352282
Third-party reviewNoNo
Applicant locationIrvine, CA, USSunnyvale, CA, US
amount percentile97th95th
Predicate Speed & CAPA Advisory Opportunity Score55/10061/100
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Official records: Triever Duo Catheter (K253419): 510(k) cleared for Inari Medical, Inc. · DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies

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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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