Cleared Traditional

K920184 - ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.

K920184 is an FDA 510(k) clearance for ANGEL WING SAFETY BLOOD COLLECTION WITH..., manufactured by Mbo Laboratories, Inc.. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K920184 · Mbo Laboratories, Inc. · Hematology device
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Feb 1992
Decision
34d
Days
Class 2
Risk

K920184 is an FDA 510(k) clearance for the ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Mbo Laboratories, Inc. (North Chelmsford, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 34 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 Mbo Laboratories, Inc. devices

FDA 510(k) Submission Details - K920184

510(k) Number K920184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1992
Decision Date February 18, 1992
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 113d · This submission: 34d
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 30
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K920184.
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
K933386 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1993
DIRECTDRAW SUPERSERUM
K921778 · International Technidyne Corp. · May 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
K921636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
VACUTAINER KIT
K914901 · Abbott Laboratories · Jan 1992
CORVAC BLOOD COLLECTION TUBE
K915213 · Sherwood Medical Co. · Jan 1992
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · Transidyne General Corp. · Feb 1990