Cleared Traditional

K010197 - EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET (FDA 510(k) Clearance)

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

K010197 · Exelint International, Co. · General Hospital
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May 2001
Decision
112d
Days
Class 2
Risk

K010197 is an FDA 510(k) clearance for the EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on May 14, 2001 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Exelint International, Co. devices

Submission Details

510(k) Number K010197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date May 14, 2001
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1173
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