Cleared Traditional

K924565 - SBS MODEL 1615

K924565 is an FDA 510(k) clearance for SBS MODEL 1615, manufactured by Stand-By-Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 730-day FDA review.

K924565 · Stand-By-Systems, Inc. · Anesthesiology device
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Sep 1994
Decision
730d
Days
Class 2
Risk

K924565 is an FDA 510(k) clearance for the SBS MODEL 1615. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Stand-By-Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 730 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Stand-By-Systems, Inc. devices

FDA 510(k) Submission Details - K924565

510(k) Number K924565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1992
Decision Date September 09, 1994
Days to Decision 730 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
590d slower than avg
Panel avg: 140d · This submission: 730d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 217
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