Cleared Traditional

K843463 - PROVIDER BAG SPIKE W/12 MICROBORE EXTEN

K843463 is an FDA 510(k) clearance for PROVIDER BAG SPIKE W/12 MICROBORE EXTEN, manufactured by Pancretec, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K843463 · Pancretec, Inc. · General Hospital
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Oct 1984
Decision
36d
Days
Class 2
Risk

K843463 is an FDA 510(k) clearance for the PROVIDER BAG SPIKE W/12 MICROBORE EXTEN. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Pancretec, Inc. (San Diego, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 36 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 Pancretec, Inc. devices

FDA 510(k) Submission Details - K843463

510(k) Number K843463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date October 11, 1984
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 851
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K843463.
ANTI-ASPIRATION VALVE
K843748 · Travenol Laboratories, S.A. · Jan 1985
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
EXTENSION SET W/INJECTION SITE
K842984 · Med Fusion Systems, Inc. · Oct 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · Y · Sep 1984
FLUID ADMINISTRATION LINE W/SPIKE 14-923
K842858 · Norton Performance Plastics Corp. · Sep 1984
T-TYPE IV EXTENSION SET
K843249 · Strato Medical Corp. · Sep 1984