Cleared Traditional

K940058 - MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER

K940058 is an FDA 510(k) clearance for MONOJECT BLOOD COLLECTION TUBES W/SAFET..., manufactured by Sherwood Medical Co.. The device is a Class 2 Chemistry device with product code GIM cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K940058 · Sherwood Medical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
117d
Days
Class 2
Risk

K940058 is an FDA 510(k) clearance for the MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 117 days - within the typical 510(k) review window.

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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K940058

510(k) Number K940058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1994
Decision Date May 02, 1994
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
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 Chemistry devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 29
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K940058.
GREINER VACUETTE BLOOD COLLECTION TUBE
K971221 · Greiner America, Inc. · May 1997
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995
CORVAC PLASTIC BLOOD COLLECTION TUBE
K944814 · Sherwood Medical Co. · Dec 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
K933939 · Organon Teknika Corp. · Feb 1994
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