Cleared Traditional

K010156 - SLEEP PAT 200 DEVICE (FDA 510(k) Clearance)

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

K010156 · Itamar Medical (C.M.) 1997 , Ltd. · Anesthesiology device
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Jun 2002
Decision
519d
Days
Class 2
Risk

K010156 is an FDA 510(k) clearance for the SLEEP PAT 200 DEVICE. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical (C.M.) 1997 , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Itamar Medical (C.M.) 1997 , Ltd. devices

Submission Details

510(k) Number K010156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date June 19, 2002
Days to Decision 519 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 139d · This submission: 519d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.