510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890503Substantially Equivalent

Sr30/sr50/sr60 Automated Sedimentation Rate

Gespac, Inc., Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890503 is the FDA 510(k) clearance record for SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE, a class I device, cleared for Gespac, Inc. on under FDA product code GKB (Device, Automated Sedimentation Rate). FDA records list 2 510(k) clearances for Gespac, Inc., from to . As of , FDA records show no recalls naming K890503.

Clearance record

Decision date
Received
(9 days to decision)
Product code
GKB Device, Automated Sedimentation Rate
Regulation
21 CFR 864.5800
Device class
Class I
Review panel
Hematology
Applicant
Gespac, Inc. 50 W. Hoover Ave., Mesa AZ
Third party review
No

Clearances, product code GKB

Trailing 12 months

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

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