Cleared Traditional

PREAMP CABLE, MODEL B400-1011PA (K003542) - FDA 510(k) Clearance

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

K003542 · Beta Biomed Services, Inc. · Anesthesiology device
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Apr 2001
Decision
140d
Days
Class 2
Risk

K003542 is an FDA 510(k) clearance for the PREAMP CABLE, MODEL B400-1011PA. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beta Biomed Services, Inc. (Crofton, US). The FDA issued a Cleared decision on April 6, 2001 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beta Biomed Services, Inc. devices

Submission Details

510(k) Number K003542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date April 06, 2001
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 189
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K974292 · Nihon Kohden America, Inc. · Jun 1998