Cleared Traditional

K772312 - FILTERSET W/Y-INJECTION SITE

K772312 is an FDA 510(k) clearance for FILTERSET W/Y-INJECTION SITE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K772312 · Abbott Laboratories · General Hospital
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Jan 1978
Decision
41d
Days
Class 2
Risk

K772312 is an FDA 510(k) clearance for the FILTERSET W/Y-INJECTION SITE, 0.2. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 41 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K772312

510(k) Number K772312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1977
Decision Date January 26, 1978
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 65
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K772312.
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
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · Abbott Laboratories · Jan 1978
AIR VENT FILTER NEEDLE, 0.45
K771536 · Jelco Laboratories · Oct 1977
INTRAVENOUS FILTER W/AUTO AIR VENT
K771826 · Jelco Laboratories · Oct 1977