Cleared Traditional

ELS AUTOMATIC TUBING CLAMP SYSTEM (K921993) - FDA 510(k) Clearance

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

K921993 · Rocky Mountain Research, Inc. · Gastroenterology & Urology device
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Jan 1994
Decision
617d
Days
Class 2
Risk

K921993 is an FDA 510(k) clearance for the ELS AUTOMATIC TUBING CLAMP SYSTEM. Classified as Clamp, Tubing, Blood, Automatic (product code FIG), Class II - Special Controls.

Submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 617 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Gastroenterology & Urology submissions.

View all Rocky Mountain Research, Inc. devices

Submission Details

510(k) Number K921993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date January 05, 1994
Days to Decision 617 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
487d slower than avg
Panel avg: 130d · This submission: 617d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIG Clamp, Tubing, Blood, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.