510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102674Substantially Equivalent

Cuff Sentry

Salter Labs, Mocksville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K102674 is the FDA 510(k) clearance record for CUFF SENTRY, a class II device, cleared for Ventlab Corp. on under FDA product code BSK (Cuff, Tracheal Tube, Inflatable). FDA records list 74 510(k) clearances for Salter Labs, from to . As of , FDA records show no recalls naming K102674.

Clearance record

Decision date
Received
(309 days to decision)
Product code
BSK Cuff, Tracheal Tube, Inflatable
Regulation
21 CFR 868.5750
Device class
Class II
Review panel
Anesthesiology
Applicant
Ventlab Corp. 155 Boyce Dr., Mocksville NC
510(k) summary
Statement
Third party review
No

Clearances, product code BSK

Trailing 12 months
1 clearance under product code BSK in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260