510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160950Substantially Equivalent

Miniscav

Sedation Systems LLC, Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160950 is the FDA 510(k) clearance record for MINISCAV, a class II device, cleared for Sedation Systems, LLC on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list one 510(k) clearance for Sedation Systems, LLC. As of , FDA records show one recall naming K160950.

Clearance record

Decision date
Received
(395 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Sedation Systems, LLC 2471 Mcmullen Booth Rd. Suite 316, Clearwater FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBN

Trailing 12 months

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

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