Cleared Traditional

K013087 - SINGLE DOSE DISPENSING PIN, MODEL 2201

K013087 is an FDA 510(k) clearance for SINGLE DOSE DISPENSING PIN, manufactured by Alaris 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 57-day FDA review.

K013087 · Alaris Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
57d
Days
Class 2
Risk

K013087 is an FDA 510(k) clearance for the SINGLE DOSE DISPENSING PIN, MODEL 2201. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Alaris Medical Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 2001 after a review of 57 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.

FDA 510(k) Submission Details - K013087

510(k) Number K013087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date November 13, 2001
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 172
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K013087.
RAPID-FILL TUBESET, MODEL 90005
K022523 · Baxa Corp. · Aug 2002
ANGELTOUCH VENTED IV ADMINISTRATION SET
K012189 · Angiplast Private , Ltd. · Mar 2002
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013
K013523 · Shire Biologics, Inc. · Jan 2002
INTER-VIAL
K010703 · Duoject Medical Systems, Inc. · Jun 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · Bioject, Inc. · Apr 2001
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
K002705 · Baxa Corp. · Mar 2001
K013087 · SINGLE DOSE DISPENSING PIN, MODEL 2201
Download PDF FDA Summary Alaris Medical System…