Cleared Traditional

K760019 - VACUUM TUBES, PEDIATRIC SIZES (J-VAC)

K760019 is an FDA 510(k) clearance for VACUUM TUBES, manufactured by Jelco Laboratories. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K760019 · Jelco Laboratories · Hematology device
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Jul 1976
Decision
39d
Days
Class 2
Risk

K760019 is an FDA 510(k) clearance for the VACUUM TUBES, PEDIATRIC SIZES (J-VAC). Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976 after a review of 39 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K760019

510(k) Number K760019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1976
Decision Date July 20, 1976
Days to Decision 39 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
74d faster than avg
Panel avg: 113d · This submission: 39d
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.