Cleared Traditional

K924709 - SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924709 · Air-Shields, Inc. · Anesthesiology device
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Jan 1996
Decision
1216d
Days
Class 2
Risk

K924709 is an FDA 510(k) clearance for the SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 1216 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Air-Shields, Inc. devices

Submission Details

510(k) Number K924709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date January 17, 1996
Days to Decision 1216 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1077d slower than avg
Panel avg: 139d · This submission: 1216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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.