Cleared Traditional

K844340 - TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP

K844340 is the FDA 510(k) clearance for TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code LHI) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K844340 · Travenol Laboratories, S.A. · General Hospital
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Jan 1985
Decision
62d
Days
Class 2
Risk

K844340 is an FDA 510(k) clearance for the TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 62 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K844340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1984
Decision Date January 09, 1985
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 71
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K844340.
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · Churchill Corp. · May 1986
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST
K853830 · Travenol Laboratories, S.A. · Nov 1985
VIAL VENT FILTER
K852467 · Baxter Healthcare Corp · Oct 1985
ACKRAD FLUID CONNECTING SET
K820937 · Ackrad Laboratories · Apr 1982
VACU-FIL TRANSFER SET
K812928 · American Pharmaseal Div. Ahsc · Dec 1981