Cleared Traditional

K760165 - FILTER, INFUSION BLOOD (1 PFF-100)

K760165 is an FDA 510(k) clearance for FILTER, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K760165 · Bentley Laboratories, Inc. · General Hospital
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Aug 1976
Decision
31d
Days
Class 2
Risk

K760165 is an FDA 510(k) clearance for the FILTER, INFUSION BLOOD (1 PFF-100). Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1976 after a review of 31 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 Bentley Laboratories, Inc. devices

FDA 510(k) Submission Details - K760165

510(k) Number K760165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 06, 1976
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 24
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K760165.
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER
K811985 · Pall Biomedical Products Co. · Jul 1981
INTERFACE 20 MICRON TRANSFUSION BLD. F.
K810855 · Abbott Laboratories · Apr 1981
BLOOD FILTER, MICROEMBOLI-ATS-F10
K780145 · Sorensen Research · Feb 1978
FILTER, TRANSFUSION BLOOD, INTERSEPT
K760222 · Surgikos, Inc. · Aug 1976