Cleared Traditional

K010703 - INTER-VIAL

K010703 is an FDA 510(k) clearance for INTER-VIAL, manufactured by Duoject Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K010703 · Duoject Medical Systems, Inc. · General Hospital
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Jun 2001
Decision
108d
Days
Class 2
Risk

K010703 is an FDA 510(k) clearance for the INTER-VIAL. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Duoject Medical Systems, Inc. (Bromont, Qc., CA). The FDA issued a Cleared decision on June 25, 2001 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Duoject Medical Systems, Inc. devices

FDA 510(k) Submission Details - K010703

510(k) Number K010703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date June 25, 2001
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
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 80
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K010703.
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · Kawasumi Laboratories Co., Ltd. · Mar 2000
CHEMO MINI SPIKE PLUS
K983794 · B. Braun of America, Inc. · Mar 1999