510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881186Substantially Equivalent

Microhematocrit Tubes, Heparin & Microhema Tube,pl

Helps Products, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881186 is the FDA 510(k) clearance record for MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL, a class II device, cleared for Helps Products, Inc. on under FDA product code GHY (Hematocrit, Tube, Rack, Sealer, Holder). FDA records list 4 510(k) clearances for Helps Products, Inc., from to . As of , FDA records show no recalls naming K881186.

Clearance record

Decision date
Received
(53 days to decision)
Product code
GHY Hematocrit, Tube, Rack, Sealer, Holder
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
Helps Products, Inc. 4469 Sw35th.St., Orlando FL
Third party review
No

Clearances, product code GHY

Trailing 12 months

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

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