Cleared Traditional

ANGELTOUCH VENTED IV ADMINISTRATION SET (K012189) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012189 · Angiplast Private , Ltd. · General Hospital
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Mar 2002
Decision
236d
Days
Class 2
Risk

K012189 is an FDA 510(k) clearance for the ANGELTOUCH VENTED IV ADMINISTRATION SET. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Angiplast Private , Ltd. (Ahmedabad, IN). The FDA issued a Cleared decision on March 5, 2002 after a review of 236 days - an extended review 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: 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 Angiplast Private , Ltd. devices

Submission Details

510(k) Number K012189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date March 05, 2002
Days to Decision 236 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
107d slower than avg
Panel avg: 129d · This submission: 236d
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 56
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K012189.
MEDLINE VIAL DECANTER
K111577 · Medline Industries, Inc. · Sep 2011
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
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997