Cleared Traditional

K032827 - KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

K032827 is an FDA 510(k) clearance for KENDALL LIFETRACE UMBILICAL BLOOD COLLE..., manufactured by Tyco Healthcare. The device is a Class 2 Hematology device with product code KSR cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K032827 · Tyco Healthcare · Hematology device
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Dec 2003
Decision
89d
Days
Class 2
Risk

K032827 is an FDA 510(k) clearance for the KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501. Classified as Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR), Class II - Special Controls.

Submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on December 8, 2003 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9100 - the FDA hematology 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 Tyco Healthcare devices

FDA 510(k) Submission Details - K032827

510(k) Number K032827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2003
Decision Date December 08, 2003
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSR Device Classification - Class 2, Special Controls

Product Code KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9100
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 Hematology devices follow this clearance model.

Regulatory Peers - KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

All 9
Devices cleared under the same product code (KSR) and FDA review panel - the closest regulatory comparables to K032827.
BLOOD FREEZING BAG
K810500 · Delmed, Inc. · Sep 1981
PLASMA FLEX
K811523 · Terumo America, Inc. · Sep 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449 · Haemonetics Corp. · Jul 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711 · Haemonetics Corp. · May 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · Haemonetics Corp. · Mar 1981
GAMBRO HEMOFREEZE-BAG
K801082 · Gambro, Inc. · Oct 1980