Cleared Traditional

K033402 - PORTABLE SLEEP DATA RECORDER (PSDR)

K033402 is an FDA 510(k) clearance for PORTABLE SLEEP DATA RECORDER (PSDR), manufactured by Pro-Tech Services, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K033402 · Pro-Tech Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K033402

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
110d slower than avg
Panel avg: 140d · This submission: 250d
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 Peers - MNR Ventilatory Effort Recorder

All 65
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K033402.
CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · Cadwell Laboratories, Inc. · Nov 2006
STARDUST II
K052573 · Respironics, Inc. · Dec 2005
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396 · Erich Jaeger, Inc. · Dec 2000
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999