Cleared Traditional

K992285 - SALTER AIRE COMPRESSOR

K992285 is an FDA 510(k) clearance for SALTER AIRE COMPRESSOR, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K992285 · Salter Labs · Anesthesiology device
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Jan 2000
Decision
184d
Days
Class 2
Risk

K992285 is an FDA 510(k) clearance for the SALTER AIRE COMPRESSOR. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on January 7, 2000 after a review of 184 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Salter Labs devices

FDA 510(k) Submission Details - K992285

510(k) Number K992285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1999
Decision Date January 07, 2000
Days to Decision 184 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
44d slower than avg
Panel avg: 140d · This submission: 184d
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 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K992285.
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
K994352 · Hudson Respiratory Care, Inc. · Mar 2000
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
K990897 · Puritan-Bennett Ireland, Ltd. · Mar 2000
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K991355 · Instrumentation Industries, Inc. · Jan 2000
EZFLOW MAX, MODEL 1007
K993558 · Piper Medical Products · Nov 1999
PRIMEAIRE
K992722 · Thayer Medical Corp. · Nov 1999
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · Invacare Corp. · Oct 1999