Cleared Traditional

K031745 - INFANT FLOW PLUS INFANT CPAP SYSTEM WIT...

K031745 is an FDA 510(k) clearance for INFANT FLOW PLUS INFANT CPAP SYSTEM WIT..., manufactured by Sensor Medics Corp.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K031745 · Sensor Medics Corp. · Anesthesiology device
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Feb 2004
Decision
253d
Days
Class 2
Risk

K031745 is an FDA 510(k) clearance for the INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Yorba Linda, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 253 days - an extended review cycle.

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. Standard predicate reliance. 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K031745

510(k) Number K031745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2003
Decision Date February 13, 2004
Days to Decision 253 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 140d · This submission: 253d
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 K031745.
RESMED S8 PRIME CPAP SYSTEM
K033841 · Resmed, Ltd. · Mar 2004
BIPAP PRO 2 BI-LEVEL SYSTEM
K032834 · Respironics, Inc. · Mar 2004
C2 NASAL MASK
K033759 · Respironics, Inc. · Feb 2004
APEX MEDICAL CPAP RT 21XX
K022650 · Apex Medical Corp. · Feb 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · Fisher &Paykel Healthcare , Ltd. · Jan 2004
MIRAGE ACTIVA MASK
K032916 · Resmed, Ltd. · Dec 2003