Cleared Traditional

K922009 - DISPOSABLE SURGICAL EXTENSION CABLE MOD...

K922009 is an FDA 510(k) clearance for DISPOSABLE SURGICAL EXTENSION CABLE MOD..., manufactured by Remington Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K922009 · Remington Medical, Inc. · Cardiovascular device
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Feb 1993
Decision
302d
Days
Class 2
Risk

K922009 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Remington Medical, Inc. (Great Neck, US). The FDA issued a Cleared decision on February 25, 1993 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Remington Medical, Inc. devices

FDA 510(k) Submission Details - K922009

510(k) Number K922009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1992
Decision Date February 25, 1993
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 51
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