510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162723Substantially Equivalent

TransFix/EDTA Vacuum Blood Collection Tubes

Caltag Medsystems Ltd, Buckingham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162723 is the FDA 510(k) clearance record for TransFix/EDTA Vacuum Blood Collection Tubes, a class II device, cleared for Caltag Medsystems, Ltd. on under FDA product code GIM (Tubes, Vacuum Sample, With Anticoagulant). FDA records list one 510(k) clearance for Caltag Medsystems, Ltd. As of , FDA records show no recalls naming K162723.

Clearance record

Decision date
Received
(266 days to decision)
Product code
GIM Tubes, Vacuum Sample, With Anticoagulant
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Caltag Medsystems, Ltd. Whiteleaf Business Centre, 11 Little Balmer, Buckingham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GIM

Trailing 12 months

FDA records hold no clearances under product code GIM in the trailing twelve months.

FDA records show no clearances under product code GIM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GIM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260