Nihon Kohden America, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 2080783

Devices: 591
Registrations: FDA
FDA recalls: 136 ongoing since 2021 (7 open in total); 1 open since before 2021

What Nihon Kohden America, Inc. makes

NIHON KOHDEN AMERICA, INC. manufactures general-purpose multi-parameter bedside monitors, electroencephalographs, evoked-potential graphic recording systems, carbon dioxide monitors, pulse oximeter probes (both single-use and reusable), neurophysiologic monitoring systems, and instrument trolleys. Their specific devices include BluPRO®, cap-ONE, Neuropack, NK-HealthProtect Wireless Surge Solution, BIS™, Life Scope TR, and Patient Triage Solution.

The company's portfolio includes Class I and Class II devices, which are listed in the FDA 510(k) and FDA UDI registries. NIHON KOHDEN AMERICA, INC. is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue591

Newest first, rows 1-50 of 591

Search and filter all 591 devices

Rows 1-50 of 591

Showing 1-50 of 591

Company details

FDA FEI number: 2080783
Address: 15353 Barranca Pkwy, Irvine, CA, 92618

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 13 recalls initiated by NIHON KOHDEN AMERICA, INC., the earliest on 2003-12-05 and the most recent on 2026-09-08. By recorded status: 7 ongoing and 6 terminated. The reasons filed fall into these groups: software or firmware, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 1
2018 0
2019 0
2020 1
2021 1
2022 1
2023 0
2024 3
2025 0
2026 1

5 initiated before 2017

Showing the 10 most recent of 13 recalls.

2026
- 8 Sep 2026 Z-0089-2027 Class II Ongoing Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA,…
  Full distribution text
  US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.
  Submission number: K102376
2024
- 18 Sep 2024 Z-0267-2025 Class II Ongoing Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Distribution: U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA,…
  Full distribution text
  U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
- 18 Sep 2024 Z-0268-2025 Class II Ongoing Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Distribution: U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA,…
  Full distribution text
  U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
- 29 Apr 2024 Z-2025-2024 Class II Ongoing Due to software issue the device may give false "SpO2 Probe Failure" alarm Distribution: U.S. Nationwide distribution in the state of IA.
2022
- 29 Apr 2022 Z-0314-2025 Class II Ongoing Due to products being shipped/distributed to customers after the products expiration date had past. Distribution: U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT. Submission number: K171765
2021
- 8 Jan 2021 Z-1162-2021 Class II Ongoing Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. Distribution: US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ,…
  Full distribution text
  US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.
  Submission number: K071058
2020
- 21 Dec 2020 Z-0865-2021 Class II Open since 2020 Medical device non-conformance to electrical safety standard (IEC 60601-1). Distribution: US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA. Submission number: K120888
2017
- 13 Mar 2017 Z-1768-2017 Class II Terminated The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. Distribution: Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile,…
  Full distribution text
  Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
  Submission number: K151080
2015
- 14 Apr 2015 Z-1543-2015 Class II Terminated Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. Distribution: US Distribution to states of: AL, CO, DE, FL, GA, HI, KY, IL, IN, MA, MD, MI, MN, MO, NC,, ND, NJ, NY.OH, PA, and WV. Submission number: K023475
2014
- 3 Jun 2014 Z-1979-2014 Class II Terminated Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate. Distribution: Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea,…
  Full distribution text
  Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
  Submission number: K102376

Show all 13 recalls

2012
- 19 Jan 2012 Z-0817-2016 Class II Terminated The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow. Distribution: Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South…
  Full distribution text
  Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.
  Submission number: K051178
2006
- 23 Aug 2006 Z-0218-2007 Unclassified (pre-2012) Terminated When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time. Distribution: Nationwide. Submission number: K991899
2003
- 5 Dec 2003 Z-0506-04 Unclassified (pre-2012) Terminated Manufacturing error results in screw affecting electromagnetic interferences. Also metal lid is not tight enough. Distribution: CA, OK, NV

Frequently asked questions

How many devices does NIHON KOHDEN AMERICA, INC. have in the registry?

The registry currently lists 591 devices for NIHON KOHDEN AMERICA, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list NIHON KOHDEN AMERICA, INC.'s devices?

Among its 50 most recently registered devices, NIHON KOHDEN AMERICA, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do NIHON KOHDEN AMERICA, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for NIHON KOHDEN AMERICA, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for NIHON KOHDEN AMERICA, INC.?

FDA recall records list 13 recalls initiated by NIHON KOHDEN AMERICA, INC., the most recent initiated on 8 Sep 2026. 7 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from NIHON KOHDEN AMERICA, INC. in the registry?

The most recently registered devices listed for NIHON KOHDEN AMERICA, INC. include SC-611R, QP-946BK, AE-918P-MD/ZA and KH-122A.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.