Cleared Traditional

K042253 - SLEEPSENSE SLEEP SENSORS

K042253 is an FDA 510(k) clearance for SLEEPSENSE SLEEP SENSORS, manufactured by S.L.P. , Ltd.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K042253

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
Combination Product No
PCCP Authorized No
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.

MNR Device Classification - Class 2, Special Controls

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 Consultant

Kema Quality B.V.
PATRICIA MURPHY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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