Cleared Traditional

K911399 - NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)

K911399 is an FDA 510(k) clearance for NASAL CPAP (CONTINUOUS POSITIVE AIR PRE..., manufactured by Aequitron Medical, Inc.. The device is a Class 1 Dental device with product code DZD cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K911399 · Aequitron Medical, Inc. · Dental device
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Sep 1991
Decision
174d
Days
Class 1
Risk

K911399 is an FDA 510(k) clearance for the NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST). Classified as Tube, Orthodontic (product code DZD), Class I - General Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on September 19, 1991 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K911399

510(k) Number K911399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date September 19, 1991
Days to Decision 174 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 127d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

DZD Device Classification - Class 1, General Controls

Product Code DZD Tube, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.