Cleared Traditional

K892117 - GENTLEHALER(R)

K892117 is an FDA 510(k) clearance for GENTLEHALER, manufactured by Schering Research. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K892117 · Schering Research · Anesthesiology device
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Jun 1989
Decision
84d
Days
Class 1
Risk

K892117 is an FDA 510(k) clearance for the GENTLEHALER(R). Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Schering Research (Kenilworth, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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.

FDA 510(k) Submission Details - K892117

510(k) Number K892117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1989
Decision Date June 23, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 30
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K892117.
FREEWAY NEBULIZER COMPRESSOR
K895592 · Lifecare Services, Inc. · Nov 1989
DEVILBISS MODEL 6610D
K894441 · Devilbiss Health Care, Inc. · Oct 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · Devilbiss Health Care, Inc. · Oct 1989
MONAGHAN AEROCHAMBER WITH MASK
K874513 · Monaghan Medical Corp. · Dec 1987
INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)
K873477 · Vortran Medical Technology 1, Inc. · Oct 1987
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · Automatic Liquid Packaging, Inc. · Apr 1987
K892117 · GENTLEHALER(R)
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