Cleared Traditional

K771985 - FILTER SAMPLER BLOOD SERUM FILTER

K771985 is the FDA 510(k) clearance for FILTER SAMPLER BLOOD SERUM FILTER by Clasrock. It is a Class 2 Hematology device (product code GIM) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K771985 · Clasrock · Hematology device
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Nov 1977
Decision
14d
Days
Class 2
Risk

K771985 is an FDA 510(k) clearance for the FILTER SAMPLER BLOOD SERUM FILTER. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Clasrock (Mchenry, US). The FDA issued a Cleared decision on November 2, 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 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 Clasrock devices

Submission Details

510(k) Number K771985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1977
Decision Date November 02, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
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 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 22
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K771985.
CORVAC BLOOD COLLECTION TUBE
K915213 · Sherwood Medical Co. · Jan 1992
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
K771305 · Organon, Inc. · Aug 1977
BLOOD COLLECTION TUBE, GRAY
K771053 · Sherwood Medical Industries · Jun 1977