Cleared Traditional

K041823 - PIONEER U121 SERIES CPAP

K041823 is an FDA 510(k) clearance for PIONEER U121 SERIES CPAP, manufactured by Merits Health Products Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K041823 · Merits Health Products Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
308d
Days
Class 2
Risk

K041823 is an FDA 510(k) clearance for the PIONEER U121 SERIES CPAP. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on May 10, 2005 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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. Elevated predicate reliance profile. 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 Merits Health Products Co., Ltd. devices

FDA 510(k) Submission Details - K041823

510(k) Number K041823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date May 10, 2005
Days to Decision 308 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
168d slower than avg
Panel avg: 140d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 287
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K041823.
BIPAP AUTO
K050759 · Respironics, Inc. · Jun 2005
GOODKNIGHT 425ST
K050072 · Nellcor Puritan Bennett, Inc. · Jun 2005
CPAP HUMIDIFIER, MODEL HC238JHU
K050904 · Fisher &Paykel Healthcare , Ltd. · May 2005
RESSCAN
K050775 · Resmed, Ltd. · May 2005
ULTRA MIRAGE II MASK
K050359 · Resmed, Ltd. · Mar 2005
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
K040202 · Salter Labs · Mar 2005