Cleared Traditional

K061103 - HAEMONETICS 40U RBC FILTER BAG

K061103 is an FDA 510(k) clearance for HAEMONETICS 40U RBC FILTER BAG, manufactured by Haemonetics Corp.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K061103 · Haemonetics Corp. · General Hospital
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May 2006
Decision
27d
Days
Class 2
Risk

K061103 is an FDA 510(k) clearance for the HAEMONETICS 40U RBC FILTER BAG. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on May 17, 2006 after a review of 27 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K061103

510(k) Number K061103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date May 17, 2006
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

CAK Device Classification - Class 2, Special Controls

Product Code CAK Microfilter, Blood Transfusion
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 Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAK Microfilter, Blood Transfusion

All 19
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K061103.
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K982822 · Baxter Healthcare Corp · Sep 1998
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · Baxter Healthcare Corp · Jul 1997
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · Pall Biomedical Products Co. · Apr 1996
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221 · Baxter Healthcare Corp · Oct 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223 · Baxter Healthcare Corp · Oct 1990
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · Pall Biomedical Products Co. · Jan 1988

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.