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Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB vs Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.: FDAPulse comparison

Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB's review days of 268 is 1.0x Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.'s 268 (90th percentile). Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB is dated 2026-09-11; Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc. 2026-09-25.

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

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB compare to Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.?

FieldExtroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden ABTempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK254051K254297
DeviceExtroducer Infusion Catheter SystemTempus ECG-MR
ApplicantSmartWise Sweden ABTempus AI, Inc.
Specialty / panelCardiovascularCardiovascular
Product codeKRASBQ
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2025-12-172025-12-31
Decision date2026-09-112026-09-25
Review time (days)268268
Third-party reviewNoNo
Applicant locationTullinge, SEChicago, IL, US
amount percentile90th90th
Predicate Speed & CAPA Advisory Opportunity Score55/10061/100
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Official records: Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB · Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, 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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