Cleared Traditional

K080375 - RMX PHYSIOLOGICAL DATA RECORDER

K080375 is the FDA 510(k) clearance for RMX PHYSIOLOGICAL DATA RECORDER by S.L.P. , Ltd.. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K080375 · S.L.P. , Ltd. · Anesthesiology device
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Sep 2008
Decision
203d
Days
Class 2
Risk

K080375 is an FDA 510(k) clearance for the RMX PHYSIOLOGICAL DATA RECORDER. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by S.L.P. , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on September 2, 2008 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all S.L.P. , Ltd. devices

Submission Details

510(k) Number K080375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2008
Decision Date September 02, 2008
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 61
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