Cleared Traditional

K013489 - KP + LFM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013489 · Pds Healthcare Products, Inc. · Anesthesiology device
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Nov 2001
Decision
38d
Days
Class 2
Risk

K013489 is an FDA 510(k) clearance for the KP + LFM. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Pds Healthcare Products, Inc. (Louisville, US). The FDA issued a Cleared decision on November 29, 2001 after a review of 38 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 Pds Healthcare Products, Inc. devices

Submission Details

510(k) Number K013489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date November 29, 2001
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 139d · This submission: 38d
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.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 78
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K013489.
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