Cleared Traditional

K070584 - SMART-ROD

K070584 is an FDA 510(k) clearance for SMART-ROD, 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 398-day FDA review.

K070584 · Duoject Medical Systems, Inc. · General Hospital
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Apr 2008
Decision
398d
Days
Class 2
Risk

K070584 is an FDA 510(k) clearance for the SMART-ROD. 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 April 2, 2008 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K070584

510(k) Number K070584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2007
Decision Date April 02, 2008
Days to Decision 398 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
269d slower than avg
Panel avg: 129d · This submission: 398d
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 K070584.
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · Nipro Medical Corporation · Nov 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · Baxter Healthcare Corporation · Oct 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
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