Cleared Traditional

K911970 - NASAL/ORAL 02 DELIVERY AND GAS SAMPLING...

K911970 is the FDA 510(k) clearance for NASAL/ORAL 02 DELIVERY AND GAS SAMPLING... by Nasorcap Ent., Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K911970 · Nasorcap Ent., Inc. · Anesthesiology device
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Aug 1992
Decision
469d
Days
Class 2
Risk

K911970 is an FDA 510(k) clearance for the NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Nasorcap Ent., Inc. (West Mifflin, US). The FDA issued a Cleared decision on August 14, 1992 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Nasorcap Ent., Inc. devices

Submission Details

510(k) Number K911970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1991
Decision Date August 14, 1992
Days to Decision 469 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
329d slower than avg
Panel avg: 140d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 80
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