510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802608Substantially Equivalent

Hematic Blood Mixer

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

K802608 is the FDA 510(k) clearance record for HEMATIC BLOOD MIXER, a class I device, cleared for Helmer Labs, Inc. on under FDA product code KSQ (Device, Blood Mixing And Blood Weighing). FDA records list 3 510(k) clearances for Helmer Labs, Inc., from to . As of , FDA records show no recalls naming K802608.

Clearance record

Decision date
Received
(51 days to decision)
Product code
KSQ Device, Blood Mixing And Blood Weighing
Regulation
21 CFR 864.9195
Device class
Class I
Review panel
Hematology
Applicant
Helmer Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSQ

Trailing 12 months

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

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