510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191858Substantially Equivalent

Pylant Monitor

Kal-Med, LLC., Kensington CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191858 is the FDA 510(k) clearance record for Pylant Monitor, a class II device, cleared for Kal-Med, LLC on under FDA product code BSK (Cuff, Tracheal Tube, Inflatable). FDA records list one 510(k) clearance for Kal-Med, LLC. As of , FDA records show no recalls naming K191858.

Clearance record

Decision date
Received
(228 days to decision)
Product code
BSK Cuff, Tracheal Tube, Inflatable
Regulation
21 CFR 868.5750
Device class
Class II
Review panel
Anesthesiology
Applicant
Kal-Med, LLC 570 Percival Ave., Kensington CT
510(k) summary
Summary PDF
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