Cleared Traditional

K811985 - ULTIPOR SQ40S BLOOD TRANSFUSION FILTER

K811985 is an FDA 510(k) clearance for ULTIPOR SQ40S BLOOD TRANSFUSION FILTER, manufactured by Pall Biomedical Products Co.. The device is a Class 2 Hematology device with product code CAK cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811985 · Pall Biomedical Products Co. · Hematology device
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Jul 1981
Decision
15d
Days
Class 2
Risk

K811985 is an FDA 510(k) clearance for the ULTIPOR SQ40S BLOOD TRANSFUSION FILTER. Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Pall Biomedical Products Co. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 880.5440 - 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 Pall Biomedical Products Co. devices

FDA 510(k) Submission Details - K811985

510(k) Number K811985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1981
Decision Date July 28, 1981
Days to Decision 15 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
98d faster than avg
Panel avg: 113d · This submission: 15d
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 Hematology devices follow this clearance model.

Regulatory Peers - CAK Microfilter, Blood Transfusion

All 22
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K811985.
INTERFACE TRANSFUSION BLOOD FILTER #30
K823261 · Medical, Inc. · Jan 1983
PEDIATRIC MICROAGGREGATE BLOOD FILTER
K812874 · Abbott Laboratories · Nov 1981
HEMA 20 MICRON TRANSFUSION BLOOD FILTER
K812697 · Abbott Laboratories · Oct 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · Abbott Laboratories · Apr 1981
BLOOD FILTER, MICROEMBOLI-ATS-F10
K780145 · Sorensen Research · Feb 1978
FILTER, INFUSION BLOOD (1 PFF-100)
K760165 · Bentley Laboratories, Inc. · Aug 1976