Cleared Traditional

K012189 - ANGELTOUCH VENTED IV ADMINISTRATION SET

K012189 is an FDA 510(k) clearance for ANGELTOUCH VENTED IV ADMINISTRATION SET, manufactured by Angiplast Private , Ltd.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K012189 · Angiplast Private , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K012189

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
Combination Product No
PCCP Authorized No
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.

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 206
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K012189.
STERI-SPOUTS
K023539 · Valumed · Dec 2002
PHASEAL
K023747 · Carmel Pharma Ab. · Nov 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · Baxa Corp. · Aug 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · Shire Biologics, Inc. · Jan 2002
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · Alaris Medical Systems, Inc. · Nov 2001
INTER-VIAL
K010703 · Duoject Medical Systems, Inc. · Jun 2001
K012189 · ANGELTOUCH VENTED IV ADMINISTRATION SET
Download PDF FDA Summary Angiplast Private , L…