Cleared Traditional

MULTIDRAW SYSTEM (K922858) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922858 · Cambridge Multi-Draw, Inc. · Chemistry device
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Nov 1992
Decision
154d
Days
Class 2
Risk

K922858 is an FDA 510(k) clearance for the MULTIDRAW SYSTEM. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Cambridge Multi-Draw, Inc. (Cambridge, US). The FDA issued a Cleared decision on November 16, 1992 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Cambridge Multi-Draw, Inc. devices

Submission Details

510(k) Number K922858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 15, 1992
Decision Date November 16, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
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 Chemistry devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 10
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K922858.
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · Sherwood Medical Co. · Dec 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · Sherwood Medical Co. · May 1994
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
K933386 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1993
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