Cleared Traditional

K810313 - HAEMONETICS 1400 ML THERAPEUTIC BAG

K810313 is an FDA 510(k) clearance for HAEMONETICS 1400 ML THERAPEUTIC BAG, manufactured by Haemonetics Corp.. The device is a Class 2 Hematology device with product code KSR cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K810313 · Haemonetics Corp. · Hematology device
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Mar 1981
Decision
54d
Days
Class 2
Risk

K810313 is an FDA 510(k) clearance for the HAEMONETICS 1400 ML THERAPEUTIC BAG. Classified as Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR), Class II - Special Controls.

Submitted by Haemonetics Corp. (Walker, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 54 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K810313

510(k) Number K810313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 31, 1981
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 113d · This submission: 54d
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 8
Devices cleared under the same product code (KSR) and FDA review panel - the closest regulatory comparables to K810313.
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
GAMBRO HEMOFREEZE-BAG
K801082 · Gambro, Inc. · Oct 1980
EMPTY TRANSFER BAG
K791673 · Delmed, Inc. · Oct 1979
TRANSFER PAK 4R 9006
K781811 · Travenol Laboratories, S.A. · Nov 1978