Cleared Traditional

K810113 - TERFUSION FINAL FILTER SET

K810113 is an FDA 510(k) clearance for TERFUSION FINAL FILTER SET, manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K810113 · Terumo Medical Corp. · General Hospital
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Mar 1981
Decision
80d
Days
Class 2
Risk

K810113 is an FDA 510(k) clearance for the TERFUSION FINAL FILTER SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on March 27, 1981 after a review of 80 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 Medical Corp. devices

FDA 510(k) Submission Details - K810113

510(k) Number K810113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1981
Decision Date March 27, 1981
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 K810113.
FIBRI-FILTER 20
K813001 · Tri-Med, Inc. · Nov 1981
HIFLO-HP
K812457 · Tri-Med, Inc. · Sep 1981
BACTAGARD
K811773 · Tri-Med, Inc. · Jul 1981
ACRODISC FILTER ASSEMBLY
K802765 · Gelman Sciences, Inc. · Jan 1981
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · Y · Aug 1980
BIMECO FILTERED EXTENSION SET
K801605 · Burron Medical Products, Inc. · Aug 1980