Cleared Abbreviated

K010009 - KOKO PEAK KP

Also marketed or referenced as:
KOKO PEAK KP+

K010009 is an FDA 510(k) clearance for KOKO PEAK KP, manufactured by Pds Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Abbreviated 510(k) pathway after a 150-day FDA review.

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

FDA 510(k) Submission Details - K010009

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
10d slower than avg
Panel avg: 140d · This submission: 150d
Pathway characteristics
Standards-based clearance path.

BZH Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K010009.
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K040723 · Microlife Intellectual Property GmbH · Jun 2004
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · Monaghan Medical Corp. · May 2003
TRUEZONE PEAK FLOW METER
K023097 · Monaghan Medical Corp. · Mar 2003
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · Monaghan Medical Corp. · Jul 1999
AEROGEAR ASTHMA ACTION KIT
K964130 · Monaghan Medical Corp. · Jan 1997
TRUZONE PEAK FLOW METER
K963089 · Monaghan Medical Corp. · Nov 1996