Cleared Traditional

K013523 - CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013

K013523 is an FDA 510(k) clearance for CISTEM FLUID TRANSFER DEVICE, manufactured by Shire Biologics, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K013523 · Shire Biologics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
76d
Days
Class 2
Risk

K013523 is an FDA 510(k) clearance for the CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Shire Biologics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 7, 2002 after a review of 76 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.

View all Shire Biologics, Inc. devices

FDA 510(k) Submission Details - K013523

510(k) Number K013523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2001
Decision Date January 07, 2002
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 121
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K013523.
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
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · Alaris Medical Systems, Inc. · Nov 2001
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · Kawasumi Laboratories Co., Ltd. · Mar 2000