510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192307Substantially Equivalent

Nihon Kohden NKV-550 Series Ventilator System

Nihon Kohden Orangemed, LLC, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192307 is the FDA 510(k) clearance record for Nihon Kohden NKV-550 Series Ventilator System, a class II device, cleared for Nihon Kohden Orangemed, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 5 510(k) clearances for Nihon Kohden Orangemed, Inc., from to . As of , FDA records show one recall naming K192307.

Clearance record

Decision date
Received
(137 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Nihon Kohden Orangemed, Inc. 1800 E. Wilshire Ave., Santa Ana CA
510(k) summary
Summary PDF
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