Cleared Traditional

K953458 - RAINBOW STEP UP SYSTEMS INC. ASTHMA HOM...

K953458 is the FDA 510(k) clearance for RAINBOW STEP UP SYSTEMS INC. ASTHMA HOM... by Raiinbow Step UP Systems, Inc.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K953458 · Raiinbow Step UP Systems, Inc. · Anesthesiology device
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Nov 1995
Decision
119d
Days
Class 2
Risk

K953458 is an FDA 510(k) clearance for the RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Raiinbow Step UP Systems, Inc. (North Andover, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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 Raiinbow Step UP Systems, Inc. devices

Submission Details

510(k) Number K953458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 21, 1995
Decision Date November 17, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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.