510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781361Substantially Equivalent

Hemoglobinometer Model 720 B

Innovative Medical Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781361 is the FDA 510(k) clearance record for HEMOGLOBINOMETER MODEL 720 B, a class II device, cleared for Innovative Medical Systems, Inc. on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 22 510(k) clearances for Innovative Medical Systems, Inc., from to . As of , FDA records show no recalls naming K781361.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
Device class
Class II
Review panel
Hematology
Applicant
Innovative Medical Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GKR

Trailing 12 months

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

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