Cleared Traditional

K972605 - EMS NASAL CPAP MASK

K972605 is an FDA 510(k) clearance for EMS NASAL CPAP MASK, manufactured by Engineered Medical Systems. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K972605 · Engineered Medical Systems · Anesthesiology device
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Jan 1998
Decision
201d
Days
Class 2
Risk

K972605 is an FDA 510(k) clearance for the EMS NASAL CPAP MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Engineered Medical Systems (Indianapolis, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 201 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 Engineered Medical Systems devices

FDA 510(k) Submission Details - K972605

510(k) Number K972605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date January 28, 1998
Days to Decision 201 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
61d slower than avg
Panel avg: 140d · This submission: 201d
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 290
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K972605.
SULLIVAN AUTOSET
K980721 · Resmed, Ltd. · Sep 1998
GOODKNIGHT 418 CPAP SYSTEM
K980365 · Nellcor Puritan Bennett, Inc. · Jul 1998
INFANT FLOW SYSTEM
K974303 · Sensor Medics Corp. · Jan 1998
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771 · Resmed, Ltd. · Jun 1997
MORPHEE PLUS ALPHA
K964019 · Nellcor Puritan Bennett, Inc. · Jun 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · Resmed, Ltd. · May 1997