Cleared Traditional

K992038 - POCKETSPACER

K992038 is an FDA 510(k) clearance for POCKETSPACER, manufactured by Ferraris Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K992038 · Ferraris Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
85d
Days
Class 2
Risk

K992038 is an FDA 510(k) clearance for the POCKETSPACER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ferraris Medical, Inc. (Washington, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 85 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 Ferraris Medical, Inc. devices

FDA 510(k) Submission Details - K992038

510(k) Number K992038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date September 09, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

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 318
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K992038.
MODEL IRC 1001 AEROSOL COMPRESSOR
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AEROCHAMBER PLUS VALVED HOLDING CHAMBER
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K980024 · Shining World Health Care Co., Ltd. · Sep 1999
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K991685 · Medic-Aid , Ltd. · Aug 1999
SALTER LABS PEP DEVICE
K991788 · Salter Labs · Aug 1999