Cleared Traditional

K953697 - THE IMS DPAP MASK

K953697 is an FDA 510(k) clearance for THE IMS DPAP MASK, manufactured by Sleepnet Corporation. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K953697 · Sleepnet Corporation · Anesthesiology device
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Jun 1996
Decision
310d
Days
Class 2
Risk

K953697 is an FDA 510(k) clearance for the THE IMS DPAP MASK, IMS MODEL NUMBER 82000. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sleepnet Corporation devices

FDA 510(k) Submission Details - K953697

510(k) Number K953697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1995
Decision Date June 13, 1996
Days to Decision 310 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 140d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K953697.
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
K961783 · Resmed, Ltd. · Aug 1996
SOLO CPAP SYSTEM
K961626 · Respironics, Inc. · Jul 1996
MAESTRO CLINICAL REMOTE CONTROL
K954572 · Respironics, Inc. · Jun 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
K960518 · Puritan Bennett Corp. · May 1996
MODEL #7354
K950849 · Devilbiss Health Care, Inc. · Feb 1996
RESPIRONICS MONARCH MINI MASK
K945938 · Respironics, Inc. · Jan 1996