Cleared Traditional

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT (K981167) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981167 · Dhd Healthcare Corp. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
78d
Days
Class 2
Risk

K981167 is an FDA 510(k) clearance for the STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Dhd Healthcare Corp. (Wampsville, US). The FDA issued a Cleared decision on June 18, 1998 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Dhd Healthcare Corp. devices

Submission Details

510(k) Number K981167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1998
Decision Date June 18, 1998
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 76
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K981167.
CLEVER TD-7001NEBULIZER
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MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · Invacare Corp. · Oct 1999
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · Invacare Corp. · Dec 1997
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K921809 · Puritan Bennett Corp. · Dec 1992