Cleared Traditional

K781815 - HEMO-NATE SYRINGE BLOOD FILTER

K781815 is an FDA 510(k) clearance for HEMO-NATE SYRINGE BLOOD FILTER, manufactured by Gisco Intl.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K781815 · Gisco Intl. · General Hospital
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Feb 1979
Decision
126d
Days
Class 2
Risk

K781815 is an FDA 510(k) clearance for the HEMO-NATE SYRINGE BLOOD FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Gisco Intl. (Walker, US). The FDA issued a Cleared decision on February 27, 1979 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gisco Intl. devices

FDA 510(k) Submission Details - K781815

510(k) Number K781815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1978
Decision Date February 27, 1979
Days to Decision 126 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 73
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K781815.
ULTIPOR SOLUTION CONTAINER FILTER
K790879 · Pall Biomedical Products Co. · Jun 1979
JELCO* DISC FILTER-0.2 MICRON
K790471 · Jelco Laboratories · Apr 1979
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · Medex, Inc. · Mar 1979
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · Abbott Laboratories · Jan 1978
AIR VENT FILTER NEEDLE, 0.45
K771536 · Jelco Laboratories · Oct 1977