Cleared Traditional

K896315 - BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY

K896315 is an FDA 510(k) clearance for BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K896315 · Bear Medical Systems, Inc. · Anesthesiology device
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Jan 1990
Decision
82d
Days
Class 2
Risk

K896315 is an FDA 510(k) clearance for the BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 82 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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K896315

510(k) Number K896315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date January 22, 1990
Days to Decision 82 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 140d · This submission: 82d
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 109
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K896315.
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K903138 · Marquest Medical Products, Inc. · Oct 1990
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · Precision Medical, Inc. · Aug 1990
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K900602 · Devilbiss Health Care, Inc. · Apr 1990
VHS 820 HUMIDIFIER, MODIFICATION
K893034 · Bear Medical Systems, Inc. · Jul 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · Fisher &Paykel Healthcare , Ltd. · Mar 1989
MODIFIED CONCHATHERM III CONTROLLED HEATER
K884150 · Respiratory Care, Inc. · Nov 1988