NIHON KOHDEN ORANGEMED, INC
FDA Regulatory Profile
NIHON KOHDEN ORANGEMED, INC has 1 FDA recall, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.
What these totals cover: FDA records filed under the name "NIHON KOHDEN ORANGEMED, INC" and its spelling variant "Nihon Kohden Orangemed".
On this page: Recalls (1) · Inspections (1) · Facilities (1) · 510(k) clearances (5)
Latest recall Z-2435-2021 · Class II · Jul 20, 2021Latest inspection Dec 1, 2021 · NAI
Latest 510(k) Mar 1, 2024
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Summary
Record counts and when each FDA source was last refreshed
Records Count Last refreshed Source as of Status
Recalls 1 Nov 8, 2026 File dated Nov 3, 2026 Current 510(k) clearances 5 Nov 8, 2026 File dated Nov 2, 2026 Current Inspections 1 Nov 13, 2026 Newest record Nov 5, 2026 Current Compliance actions 0 Nov 2, 2026 Newest record Oct 29, 2026 Current
1 recall record on Jul 20, 2021.
Number Class Product Date
Z-2435-2021 Class II Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden… Jul 20, 2021
1 inspection on Dec 1, 2021.
NAI No objectionable conditions or practices were found during the inspection.
VAI Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI Regulatory and/or administrative actions are recommended.
Look up the inspector observations behind these results with the FDA 483 search , or check for formal enforcement with the FDA warning letter search .
1 inspected site, newest inspection first.
Facility Location Inspections Latest
FEI 3014631252 Santa Ana, CA 1 Dec 1, 2021
5 510(k) clearances from Dec 7, 2018 to Mar 1, 2024.
K-Number Device Date
K231778 Nihon Kohden NKV-550 Series Ventilator System Mar 1, 2024 K222644 Nihon Kohden NKV-440 Ventilator System May 31, 2023 K213521 Nihon Kohden NKV-330 Ventilator System Jul 1, 2022 K192307 Nihon Kohden NKV-550 Series Ventilator System Jan 10, 2020 K181695 Nihon Kohden NKV-550 Series Ventilator System Dec 7, 2018
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