Cleared Traditional

K962713 - DPAP STEALTH SLEEPNET MODEL NUMBER 84000

K962713 is an FDA 510(k) clearance for DPAP STEALTH SLEEPNET MODEL NUMBER 84000, 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 103-day FDA review.

K962713 · Sleepnet Corporation · Anesthesiology device
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Oct 1996
Decision
103d
Days
Class 2
Risk

K962713 is an FDA 510(k) clearance for the DPAP STEALTH SLEEPNET MODEL NUMBER 84000. 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 October 23, 1996 after a review of 103 days - within the typical 510(k) review window.

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 Sleepnet Corporation devices

FDA 510(k) Submission Details - K962713

510(k) Number K962713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1996
Decision Date October 23, 1996
Days to Decision 103 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
37d faster than avg
Panel avg: 140d · This submission: 103d
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 K962713.
BIPAP DUET SYSTEM
K964363 · Respironics, Inc. · Jan 1997
WHISPER SWIVEL II EXHALATION PORT
K962203 · Respironics, Inc. · Dec 1996
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
SULLIVAN VPAP II ST NASAL VPAP SYSTEM
K961783 · Resmed, Ltd. · Aug 1996