Cleared Traditional

K905384 - DAVID SIMMONDS ANESTHESIA EXTENSION TUBES

K905384 is an FDA 510(k) clearance for DAVID SIMMONDS ANESTHESIA EXTENSION TUBES, manufactured by Sparta Surgical Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K905384 · Sparta Surgical Corp. · General Hospital
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Mar 1991
Decision
113d
Days
Class 2
Risk

K905384 is an FDA 510(k) clearance for the DAVID SIMMONDS ANESTHESIA EXTENSION TUBES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sparta Surgical Corp. (Hammonton, US). The FDA issued a Cleared decision on March 22, 1991 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sparta Surgical Corp. devices

FDA 510(k) Submission Details - K905384

510(k) Number K905384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1990
Decision Date March 22, 1991
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 374
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K905384.
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DISPOSABLE CORONARY CONTROL SYRINGE
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AUTOPEN
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