Cleared Traditional

MAESTRO CLINICAL REMOTE CONTROL (K954572) - FDA 510(k) Clearance

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

K954572 · Respironics, Inc. · Anesthesiology device
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Jun 1996
Decision
268d
Days
Class 2
Risk

K954572 is an FDA 510(k) clearance for the MAESTRO CLINICAL REMOTE CONTROL. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on June 26, 1996 after a review of 268 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Respironics, Inc. devices

Submission Details

510(k) Number K954572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date June 26, 1996
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 118
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K954572.
VIRTUOSO SMART CPAP SYSTEM
K953930 · Respironics, Inc. · Sep 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
K961915 · Respironics, Inc. · Aug 1996
SOLO CPAP SYSTEM
K961626 · Respironics, Inc. · Jul 1996
RESPIRONICS MONARCH MINI MASK
K945938 · Respironics, Inc. · Jan 1996
GEL MASK
K954207 · Respironics, Inc. · Jan 1996
ARIA CPAP SYSTEM
K953341 · Respironics, Inc. · Jan 1996