510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884389Substantially Equivalent

Modified 225/Simv Volume Ventilator

Monaghan Medical Corp., Plattsburgh NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884389 is the FDA 510(k) clearance record for MODIFIED 225/SIMV VOLUME VENTILATOR, a class II device, cleared for Monaghan Medical Corp. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 35 510(k) clearances for Monaghan Medical Corp., from to . As of , FDA records show no recalls naming K884389.

Clearance record

Decision date
Received
(510 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Monaghan Medical Corp. Franklyn Bldg., Plattsburgh NY
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260