510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780340Substantially Equivalent

Imv System

Lkb Instruments, Inc., KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780340 is the FDA 510(k) clearance record for IMV SYSTEM, a class II device, cleared for Lkb Instruments, Inc. on under FDA product code CBD (Bottle, Collection, Breathing System (Calibrated)). FDA records list 52 510(k) clearances for Lkb Instruments, Inc., from to . As of , FDA records show no recalls naming K780340.

Clearance record

Decision date
Received
(271 days to decision)
Product code
CBD Bottle, Collection, Breathing System (Calibrated)
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Lkb Instruments, Inc.
Third party review
No

Clearances, product code CBD

Trailing 12 months

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

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