Cleared Traditional

K061996 - SANDMAN POCKET (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061996 · Eb Neuro S.P.A. · Anesthesiology device
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Oct 2006
Decision
81d
Days
Class 2
Risk

K061996 is an FDA 510(k) clearance for the SANDMAN POCKET. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Eb Neuro S.P.A. (Carmel, US). The FDA issued a Cleared decision on October 3, 2006 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eb Neuro S.P.A. devices

Submission Details

510(k) Number K061996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2006
Decision Date October 03, 2006
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 139d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.