Cleared Traditional

K941291 - MONOJECT SAMPLETTE SEPARATOR TUBE

K941291 is an FDA 510(k) clearance for MONOJECT SAMPLETTE SEPARATOR TUBE, manufactured by Sherwood Medical Co.. The device is a Class 1 Chemistry device with product code GIO cleared through the Traditional 510(k) pathway after a 224-day FDA review.

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

FDA 510(k) Submission Details - K941291

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence.

GIO Device Classification - Class 1, General Controls

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.

Regulatory Peers - GIO Tube, Collection, Capillary Blood

All 12
Devices cleared under the same product code (GIO) and FDA review panel - the closest regulatory comparables to K941291.
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · Innovative Medical Technologies, Inc. · Sep 1997
MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR
K875061 · Sherwood Medical Co. · Jan 1988
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · Ventrex Laboratories, Inc. · Oct 1987
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · Corning Medical & Scientific · Mar 1985
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · Abco Dealers, Inc. · Nov 1984
MONOJET SAMPLETTE ADAPTERS
K832578 · Sherwood Medical Co. · Aug 1983