Cleared Traditional

K984085 - RITEFLO SPACER

K984085 is an FDA 510(k) clearance for RITEFLO SPACER, manufactured by Aeromax Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K984085 · Aeromax Technologies, Inc. · Anesthesiology device
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Aug 1999
Decision
262d
Days
Class 2
Risk

K984085 is an FDA 510(k) clearance for the RITEFLO SPACER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Aeromax Technologies, Inc. (Phoenix, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 262 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 Aeromax Technologies, Inc. devices

FDA 510(k) Submission Details - K984085

510(k) Number K984085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date August 05, 1999
Days to Decision 262 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 140d · This submission: 262d
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 K984085.
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
K980024 · Shining World Health Care Co., Ltd. · Sep 1999
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
K991685 · Medic-Aid , Ltd. · Aug 1999
SALTER LABS PEP DEVICE
K991788 · Salter Labs · Aug 1999
SIDESTREAM NEBULIZER
K991725 · Inspired Medical Products , Ltd. · Jul 1999
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K990384 · Piper Medical Products · Apr 1999
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · Ambu, Inc. · Apr 1999