Cleared Traditional

K864636 - ERYPUR B

K864636 is an FDA 510(k) clearance for ERYPUR B, manufactured by Organon Teknika Corp.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K864636 · Organon Teknika Corp. · General Hospital
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Jan 1987
Decision
49d
Days
Class 2
Risk

K864636 is an FDA 510(k) clearance for the ERYPUR B. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Kensington, US). The FDA issued a Cleared decision on January 14, 1987 after a review of 49 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K864636

510(k) Number K864636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1986
Decision Date January 14, 1987
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAK Microfilter, Blood Transfusion

All 19
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K864636.
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · Pall Biomedical Products Co. · Jan 1988
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873667 · Pall Biomedical Products Co. · Jan 1988
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · Travenol Laboratories, S.A. · Oct 1987
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · Cobe Laboratories, Inc. · Mar 1986
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · Travenol Laboratories, S.A. · Jan 1983
HEMA - NV TRANS. BLOOD FILTER 100/800
K830014 · Abbott Laboratories · Jan 1983