510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801513Substantially Equivalent

Tissue Processing System

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

K801513 is the FDA 510(k) clearance record for TISSUE PROCESSING SYSTEM, a class I device, cleared for Innovative Medical Systems, Inc. on under FDA product code IEO (Processor, Tissue, Automated). FDA records list 22 510(k) clearances for Innovative Medical Systems, Inc., from to . As of , FDA records show no recalls naming K801513.

Clearance record

Decision date
Received
(28 days to decision)
Product code
IEO Processor, Tissue, Automated
Regulation
21 CFR 864.3875
Device class
Class I
Review panel
Pathology
Applicant
Innovative Medical Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IEO

Trailing 12 months

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

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