510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830475Substantially Equivalent

Brain Module Rj-Z10

Instrumentation Industries, Incorporated, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830475 is the FDA 510(k) clearance record for BRAIN MODULE RJ-Z10, a class I device, cleared for Instrumentation Industries, Inc. on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 45 510(k) clearances for INSTRUMENTATION INDUSTRIES, INCORPORATED, from to . As of , FDA records show no recalls naming K830475.

Clearance record

Decision date
Received
(113 days to decision)
Product code
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Regulation
21 CFR 868.5240
Device class
Class I
Review panel
Anesthesiology
Applicant
Instrumentation Industries, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CAI

Trailing 12 months

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

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