Cleared Traditional

K984254 - INFANT FLOW NCPAP MASKS

K984254 is an FDA 510(k) clearance for INFANT FLOW NCPAP MASKS, 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 89-day FDA review.

K984254 · Sensor Medics Corp. · Anesthesiology device
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Feb 1999
Decision
89d
Days
Class 2
Risk

K984254 is an FDA 510(k) clearance for the INFANT FLOW NCPAP MASKS. 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 24, 1999 after a review of 89 days - a notably fast clearance 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: 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K984254

510(k) Number K984254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date February 24, 1999
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 K984254.
MONARCH II MINI MASK
K992336 · Respironics, Inc. · Aug 1999
SULLIVAN AUTOSET NASAL CPAP SYSTEM
K984428 · Resmed, Ltd. · Jul 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SULLIVAN MIRAGE FULL FACE MASK
K982530 · Resmed, Ltd. · Oct 1998
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998