Cleared Traditional

K963025 - SLEEPNET HUMIDIFIER

K963025 is an FDA 510(k) clearance for SLEEPNET HUMIDIFIER, manufactured by Sleepnet Corporation. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K963025 · Sleepnet Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
88d
Days
Class 2
Risk

K963025 is an FDA 510(k) clearance for the SLEEPNET HUMIDIFIER,(84200 PACKAGED). Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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 Sleepnet Corporation devices

FDA 510(k) Submission Details - K963025

510(k) Number K963025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1996
Decision Date November 01, 1996
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 123
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K963025.
SCT 3000 HEATED HUMIDIFIER
K970478 · Marquest Medical Products, Inc. · Jul 1997
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER
K962223 · Marquest Medical Products, Inc. · Jan 1997
HUMIDIFIER ADAPTER
K962079 · Automatic Liquid Packaging, Inc. · Jul 1996
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994