Cleared Traditional

K870995 - SCALP VEIN SET

K870995 is an FDA 510(k) clearance for SCALP VEIN SET, manufactured by Mac Lee Medical Products. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K870995 · Mac Lee Medical Products · General Hospital
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Jul 1987
Decision
142d
Days
Class 2
Risk

K870995 is an FDA 510(k) clearance for the SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Mac Lee Medical Products (Topeka, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 142 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 Mac Lee Medical Products devices

FDA 510(k) Submission Details - K870995

510(k) Number K870995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1987
Decision Date July 31, 1987
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 805
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K870995.
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