Cleared Traditional

K883612 - LECTROSPIRAL

K883612 is an FDA 510(k) clearance for LECTROSPIRAL, manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K883612 · Vygon Corp. · General Hospital
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Sep 1988
Decision
38d
Days
Class 2
Risk

K883612 is an FDA 510(k) clearance for the LECTROSPIRAL. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 38 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 Vygon Corp. devices

FDA 510(k) Submission Details - K883612

510(k) Number K883612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date September 29, 1988
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K883612.
WINGED INFUSION SET
K885264 · E-Z-Em, Inc. · Jan 1989
STANDARD ADMINISTRATION SETS
K885030 · 3M Company · Jan 1989
VALLEYLAB I.V. ADMINISTRATION SETS
K883318 · Valleylab, Inc. · Oct 1988
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · Baxter Healthcare Corp · Sep 1988
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080
K882302 · Y · Jul 1988
EXTENDED LIFE INJECTION SITE
K882007 · Baxter Healthcare Corp · Jun 1988