Cleared Traditional

K862491 - EXEL BUTTERFLY SCALP VEIN SET

K862491 is an FDA 510(k) clearance for EXEL BUTTERFLY SCALP VEIN SET, manufactured by Exel Intl.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K862491 · Exel Intl. · General Hospital
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Aug 1986
Decision
57d
Days
Class 2
Risk

K862491 is an FDA 510(k) clearance for the EXEL BUTTERFLY SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Exel Intl. (Culver City, US). The FDA issued a Cleared decision on August 27, 1986 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Exel Intl. devices

FDA 510(k) Submission Details - K862491

510(k) Number K862491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date August 27, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
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 789
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K862491.
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · Y · Dec 1986
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
BAG SPIKE EXTENSION SET
K863814 · Med Fusion Systems, Inc. · Oct 1986
LUER LOCK ADAPTER/NUT
K862653 · Mallinckrodt Critical Care · Jul 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609 · Ipax, Inc. · Jun 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182 · Ipax, Inc. · Jun 1986