Cleared Traditional

SOLO CPAP SYSTEM (K961626) - FDA 510(k) Clearance

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

K961626 · Respironics, Inc. · Anesthesiology device
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Jul 1996
Decision
83d
Days
Class 2
Risk

K961626 is an FDA 510(k) clearance for the SOLO CPAP SYSTEM. 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 July 18, 1996 after a review of 83 days - a notably fast clearance 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: 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 Respironics, Inc. devices

Submission Details

510(k) Number K961626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date July 18, 1996
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 K961626.
PRESSURE VALVE
K963250 · Respironics, Inc. · Nov 1996
VIRTUOSO SMART CPAP SYSTEM
K953930 · Respironics, Inc. · Sep 1996
SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
K961915 · Respironics, Inc. · Aug 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572 · Respironics, Inc. · Jun 1996
RESPIRONICS MONARCH MINI MASK
K945938 · Respironics, Inc. · Jan 1996
GEL MASK
K954207 · Respironics, Inc. · Jan 1996