510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K932588Substantially Equivalent

Pediatric Temperature Monitoring Circuits

Merit Medical Systems, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932588 is the FDA 510(k) clearance record for PEDIATRIC TEMPERATURE MONITORING CIRCUITS, a class I device, cleared for Merit Medical Systems, Inc. on under FDA product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)). FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K932588.

Clearance record

Decision date
Received
(55 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
Merit Medical Systems, Inc. 8102 Woodland Dr/., Indianapolis IN
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260