Cleared Traditional

K771430 - BLOOD FILTER

K771430 is the FDA 510(k) clearance for BLOOD FILTER by Terumo America, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K771430 · Terumo America, Inc. · General Hospital
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Sep 1977
Decision
50d
Days
Class 2
Risk

K771430 is an FDA 510(k) clearance for the BLOOD FILTER, W/SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977 after a review of 50 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 Terumo America, Inc. devices

Submission Details

510(k) Number K771430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1977
Decision Date September 20, 1977
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 43
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K771430.
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
CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET
K771498 · Travenol Laboratories, S.A. · Aug 1977
IV PUMP FILTERSET, UNIVERSAL
K770843 · Abbott Laboratories · Jun 1977
0.22/UM FILTERSET W/Y-INJECTION SITE
K770182 · Abbott Laboratories · Mar 1977