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Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. vs Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.: FDAPulse comparison

Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.'s review days of 268 is 1.0x Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.'s 266 (90th percentile). Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. is dated 2026-10-02; Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. 2026-10-02.

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 Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. compare to Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.?

FieldVentricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK260044K260064
DeviceVentricular Catheters, Thomale CatheterNeurora
ApplicantAesculap, Inc.Argus Cognitive, Inc.
Specialty / panelNeurologyNeurology
Product codeJXGQPF
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-01-072026-01-09
Decision date2026-10-022026-10-02
Review time (days)268266
Third-party reviewNoNo
Applicant locationCenter Valley, PA, USHanover, NH, US
amount percentile90th86th
Predicate Speed & CAPA Advisory Opportunity Score61/10061/100
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Official records: Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. · Neurora (K260064): 510(k) cleared for Argus Cognitive, 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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