Cleared Traditional

K944083 - MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE

K944083 is an FDA 510(k) clearance for MONOJECT SAMPLETTE COLLECTION TUBE, manufactured by Sherwood Medical Co.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K944083 · Sherwood Medical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
277d
Days
Class 2
Risk

K944083 is an FDA 510(k) clearance for the MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on May 26, 1995 after a review of 277 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K944083

510(k) Number K944083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date May 26, 1995
Days to Decision 277 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
189d slower than avg
Panel avg: 88d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 168
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K944083.
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · Becton Dickinson Vacutainer Systems · Mar 1996
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
K936240 · Sudormed, Inc. · Mar 1996
PRO-VENT, LINE DRAW, PULSATOR
K952516 · Smiths Industries Medical Systems, Inc. · Jul 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
K945777 · Smiths Industries Medical Systems, Inc. · Dec 1994