510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942827Substantially Equivalent

Sentry Insertion Tray

Sentry Medical Products, Inc., Lombard IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942827 is the FDA 510(k) clearance record for SENTRY INSERTION TRAY, a class II device, cleared for Sentry Medical Products, Inc. on under FDA product code FOS (Catheter, Umbilical Artery). FDA records list 13 510(k) clearances for Sentry Medical Products, Inc., from to . As of , FDA records show no recalls naming K942827.

Clearance record

Decision date
Received
(141 days to decision)
Product code
FOS Catheter, Umbilical Artery
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Sentry Medical Products, Inc. 331 S. Eisenhower Ln., Lombard IL
510(k) summary
Statement
Third party review
No

Clearances, product code FOS

Trailing 12 months

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

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