Cleared Traditional

K871841 - THREE FLUID I.V. SETS

K871841 is an FDA 510(k) clearance for THREE FLUID I.V. SETS, manufactured by Panamedix, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K871841 · Panamedix, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
43d
Days
Class 2
Risk

K871841 is an FDA 510(k) clearance for the THREE FLUID I.V. SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Panamedix, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on June 24, 1987 after a review of 43 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 Panamedix, Inc. devices

FDA 510(k) Submission Details - K871841

510(k) Number K871841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1987
Decision Date June 24, 1987
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K871841.
CHURCHILL TPN ADMINISTRATION SET
K872123 · Churchill Corp. · Oct 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
K872795 · Medex, Inc. · Sep 1987
THE GRIPPER(TM) PORT-A-CATH NEEDLES
K870866 · Pharmacia, Inc. · Jun 1987
IV PUMP SET
K871086 · Churchill Corp. · Jun 1987
CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
K871732 · Churchill Corp. · Jun 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581 · Strato Medical Corp. · Apr 1987