510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962596Substantially Equivalent

Customed Blood Extraction Kit

Customed, Inc, Great Neck, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962596 is the FDA 510(k) clearance record for CUSTOMED BLOOD EXTRACTION KIT, a class II device, cleared for Customed, Inc. on under FDA product code GJE (Tray, Blood Collection). FDA records list 37 510(k) clearances for Customed, Inc., from to . As of , FDA records show no recalls naming K962596.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GJE Tray, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Customed, Inc. 55 Northern Blvd., Suite 410, Great Neck, NY
510(k) summary
Summary
Third party review
No

Clearances, product code GJE

Trailing 12 months

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

FDA records show no clearances under product code GJE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GJE, 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