Cleared Traditional

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 (K013523) - FDA 510(k) Clearance

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

K013523 · Shire Biologics, Inc. · General Hospital
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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

Submission Details

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.

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 K013523.
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