Cleared Traditional

K905201 - TPN FLUID TRANSFER SET

K905201 is an FDA 510(k) clearance for TPN FLUID TRANSFER SET, manufactured by Mcgaw, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K905201 · Mcgaw, Inc. · General Hospital
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Jan 1991
Decision
43d
Days
Class 2
Risk

K905201 is an FDA 510(k) clearance for the TPN FLUID TRANSFER SET. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Mcgaw, Inc. (Irvine, US). The FDA issued a Cleared decision on January 2, 1991 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 Mcgaw, Inc. devices

FDA 510(k) Submission Details - K905201

510(k) Number K905201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date January 02, 1991
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.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 95
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K905201.
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
LUER LOCK TRANSFER PIN
K901063 · Acacia, Inc. · Jul 1990
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · Abbott Laboratories · Jun 1990
PHARMULATOR
K896990 · Acacia, Inc. · Mar 1990