Cleared Traditional

K910793 - RECONSTITUTION DEVICE

K910793 is an FDA 510(k) clearance for RECONSTITUTION DEVICE, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K910793 · Baxter Healthcare Corp · General Hospital
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Mar 1991
Decision
24d
Days
Class 2
Risk

K910793 is an FDA 510(k) clearance for the RECONSTITUTION DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 24 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K910793

510(k) Number K910793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date March 21, 1991
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 135
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K910793.
NUTRIMIX MICROCOMPOUNDER
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K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 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