Cleared Traditional

K033402 - PORTABLE SLEEP DATA RECORDER (PSDR) (FDA 510(k) Clearance)

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

K033402 · Pro-Tech Services, Inc. · Anesthesiology device
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Jun 2004
Decision
250d
Days
Class 2
Risk

K033402 is an FDA 510(k) clearance for the PORTABLE SLEEP DATA RECORDER (PSDR). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Pro-Tech Services, Inc. (Mukilteo, US). The FDA issued a Cleared decision on June 30, 2004 after a review of 250 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 Pro-Tech Services, Inc. devices

Submission Details

510(k) Number K033402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2003
Decision Date June 30, 2004
Days to Decision 250 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
111d slower than avg
Panel avg: 139d · This submission: 250d
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.