Cleared Traditional

K771693 - CLIRANS BLOOD LINES SET

K771693 is the FDA 510(k) clearance for CLIRANS BLOOD LINES SET by Terumo America, Inc.. It is a Class 2 Hematology device (product code FJK) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K771693 · Terumo America, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
14d
Days
Class 2
Risk

K771693 is an FDA 510(k) clearance for the CLIRANS BLOOD LINES SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), 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 14 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 876.5820 - the FDA hematology 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 K771693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1977
Decision Date September 20, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Hematology devices follow this clearance model.

Regulatory Peers - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 42
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K771693.
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053 · Erika, Inc. · Dec 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054 · Erika, Inc. · Dec 1979
ARTERIOVENOUS BLOOD TUBING SETS
K780681 · Extracorporeal Medical Specialities, Inc. · Jun 1978
ARTERIOVENOUS BLOOD TUBING SETS
K761326 · Extracorporeal Medical Specialities, Inc. · Jan 1977