Cleared Traditional

K781815 - HEMO-NATE SYRINGE BLOOD FILTER

K781815 is the FDA 510(k) clearance for HEMO-NATE SYRINGE BLOOD FILTER by Gisco Intl.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 61
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K781815.
LARGE VOLUME 5 MICRON CONICAL FILTER
K792021 · National Patent Development Corp. · Oct 1979
ULTIPOR SOLUTION CONTAINER FILTER
K790879 · Pall Biomedical Products Co. · Jun 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
PRIMARY PIGGYBACK VENOSET W/ FILTER
K771594 · Abbott Laboratories · Sep 1977