Cleared Traditional

K882501 - ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM ...

K882501 is an FDA 510(k) clearance for ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM ..., manufactured by Terumo Medical Corp.. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K882501 · Terumo Medical Corp. · Hematology device
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Jul 1988
Decision
31d
Days
Class 2
Risk

K882501 is an FDA 510(k) clearance for the ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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 Medical Corp. devices

FDA 510(k) Submission Details - K882501

510(k) Number K882501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date July 18, 1988
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIM Device Classification - Class 2, Special Controls

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - GIM Tubes, Vacuum Sample, With Anticoagulant

All 24
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K882501.
VACUTAINER KIT
K914901 · Abbott Laboratories · Jan 1992
CORVAC BLOOD COLLECTION TUBE
K915213 · Sherwood Medical Co. · Jan 1992
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
J-VAC VACUUM TUBE
K771874 · Jelco Laboratories · Dec 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · Organon, Inc. · Aug 1977