Cleared Traditional

K042253 - SLEEPSENSE SLEEP SENSORS

K042253 is the FDA 510(k) clearance for SLEEPSENSE SLEEP SENSORS by S.L.P. , Ltd.. It is a Class 2 Anesthesiology device (product code MNR) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K042253 · S.L.P. , Ltd. · Anesthesiology device
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Oct 2004
Decision
47d
Days
Class 2
Risk

K042253 is an FDA 510(k) clearance for the SLEEPSENSE SLEEP SENSORS. 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 October 6, 2004 after a review of 47 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 S.L.P. , Ltd. devices

Submission Details

510(k) Number K042253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2004
Decision Date October 06, 2004
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
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
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K042253.
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SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
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K990199 · Respironics, Inc. · Apr 1999