Cleared Traditional

K941291 - MONOJECT SAMPLETTE SEPARATOR TUBE (FDA 510(k) Clearance)

Class I Chemistry device.

K941291 · Sherwood Medical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
224d
Days
Class 1
Risk

K941291 is an FDA 510(k) clearance for the MONOJECT SAMPLETTE SEPARATOR TUBE. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Sherwood Medical Co. (St.Louis, US). The FDA issued a Cleared decision on October 27, 1994 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6150 - 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

Submission Details

510(k) Number K941291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1994
Decision Date October 27, 1994
Days to Decision 224 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIO Tube, Collection, Capillary Blood
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.