Cleared Traditional

K830057 - 20 MICRON HIGH CAPACITY TRANS/FILTER

K830057 is the FDA 510(k) clearance for 20 MICRON HIGH CAPACITY TRANS/FILTER by Travenol Laboratories, S.A.. It is a Class 2 General Hospital device (product code CAK) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K830057 · Travenol Laboratories, S.A. · General Hospital
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Jan 1983
Decision
19d
Days
Class 2
Risk

K830057 is an FDA 510(k) clearance for the 20 MICRON HIGH CAPACITY TRANS/FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 19 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K830057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date January 26, 1983
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 129d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - CAK Microfilter, Blood Transfusion

All 14
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K830057.
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · Travenol Laboratories, S.A. · Oct 1987
ERYPUR B
K864636 · Organon Teknika Corp. · Jan 1987
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · Cobe Laboratories, Inc. · Mar 1986
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · Abbott Laboratories · Jan 1983
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · Abbott Laboratories · Nov 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · Abbott Laboratories · Oct 1981