510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944083Substantially Equivalent

Monoject(r) Samplette(r) Collection Tube

Sherwood Medical Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944083 is the FDA 510(k) clearance record for MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE, a class II device, cleared for Sherwood Medical Co. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K944083.

Clearance record

Decision date
Received
(277 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sherwood Medical Co. 1915 Olive St., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code JKA

Trailing 12 months
6 clearances under product code JKA in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260