510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760086Substantially Equivalent

Tray, Blood Sampling (Pulsator II)

Concord Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760086 is the FDA 510(k) clearance record for TRAY, BLOOD SAMPLING (PULSATOR II), a class II device, cleared for Concord Laboratories, Inc. on under FDA product code GJE (Tray, Blood Collection). FDA records list 42 510(k) clearances for Concord Laboratories, Inc., from to . As of , FDA records show no recalls naming K760086.

Clearance record

Decision date
Received
(25 days to decision)
Product code
GJE Tray, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Concord Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
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