Cleared Abbreviated

PULSE OXIMETER ADAPTER CABLES (K052544) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052544 · American I.V. Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
379d
Days
Class 2
Risk

K052544 is an FDA 510(k) clearance for the PULSE OXIMETER ADAPTER CABLES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by American I.V. Products, Inc. (Hanover, US). The FDA issued a Cleared decision on September 29, 2006 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all American I.V. Products, Inc. devices

Submission Details

510(k) Number K052544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date September 29, 2006
Days to Decision 379 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 140d · This submission: 379d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 243
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