Cleared Abbreviated

K010009 - KOKO PEAK KP (FDA 510(k) Clearance)

Also includes:
KOKO PEAK KP+

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K010009 · Pds Healthcare Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
150d
Days
Class 2
Risk

K010009 is an FDA 510(k) clearance for the KOKO PEAK KP. 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 June 1, 2001 after a review of 150 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Pds Healthcare Products, Inc. devices

Submission Details

510(k) Number K010009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2001
Decision Date June 01, 2001
Days to Decision 150 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 139d · This submission: 150d
Pathway characteristics
Standards-based clearance path.

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 K010009.
Peak Flow Meter
K241338 · Chongqing Moffy Innovation Technology Co., Ltd. · Dec 2024
Aluna 2
K232588 · Knox Medical Diagnostics · Nov 2024
Electronic Peak Flow Meter
K230423 · Taian Dalu Medical Instrument Co., Ltd. · Feb 2024
TD-7301 Peak Flow meter
K222810 · Gostar Co., Ltd. · Dec 2023
Peak flow meter
K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021