Cleared Traditional

K933889 - PERSONAL BEST LOW RANGE

K933889 is the FDA 510(k) clearance for PERSONAL BEST LOW RANGE by Healthscan Products, Inc.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K933889 · Healthscan Products, Inc. · Anesthesiology device
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Sep 1993
Decision
30d
Days
Class 2
Risk

K933889 is an FDA 510(k) clearance for the PERSONAL BEST LOW RANGE. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Healthscan Products, Inc. (Cedar Grove, US). The FDA issued a Cleared decision on September 9, 1993 after a review of 30 days - a notably fast clearance cycle.

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: 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 Healthscan Products, Inc. devices

Submission Details

510(k) Number K933889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date September 09, 1993
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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.