Cleared Traditional

Nihon Kohden NKV-550 Series Ventilator System

K181695 · Nihon Kohden Orangemed, Inc. · Anesthesiology
Dec 2018
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K181695 is an FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Nihon Kohden Orangemed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 7, 2018, 163 days after receiving the submission on June 27, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K181695 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2018
Decision Date December 07, 2018
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

Similar Devices — CBK Ventilator, Continuous, Facility Use

All 502
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits ? Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025
AF531 Oro-Nasal SE Face Mask
K243394 · Respironics, Inc. · Dec 2024