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Medical device manufacturer

Nihon Kohden America Inc

Nihon Kohden America Inc holds 166 FDA 510(k) clearances across 36 product codes. Median elapsed review time is 94 days. openFDA lists 12 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
166
Product codes
36
Median review
94 days
Recall records
12

How does FDA spell Nihon Kohden America Inc?

FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
NIHON KOHDEN AMERICA, INC.device/registrationlistingnormalised
Nihon Kohden America Incdevice/recallnormalised
Nihon Kohden America Incdevice/enforcementnormalised
Nihon Kohden America, Inc.device/510knormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Nihon Kohden America Inc file in?

36 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
DPSElectrocardiograph2149 days
DSIDetector And Alarm, Arrhythmia18171 days
GWQFull-Montage Standard Electroencephalograph1575 days
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1184 days
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)1090 days
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase9151 days
OLVStandard Polysomnograph With Electroencephalograph959 days
LDDDc-Defibrillator, Low-Energy, (Including Paddles)895 days
GWFStimulator, Electrical, Evoked Response7112 days
DQAOximeter6150 days
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency5154 days
BZQMonitor, Breathing Frequency3218 days
DXGComputer, Diagnostic, Pre-Programmed, Single-Function317 days
DXJDisplay, Cathode-Ray Tube, Medical380 days
GWLAmplifier, Physiological Signal3196 days
DPWFlowmeter, Blood, Cardiovascular228 days
DRSTransducer, Blood-Pressure, Extravascular270 days
DSFRecorder, Paper Chart276 days
DXNSystem, Measurement, Blood-Pressure, Non-Invasive270 days
GWEStimulator, Photic, Evoked Response294 days
GWKConditioner, Signal, Physiological258 days
GYBMedia, Electroconductive2114 days
IKNElectromyograph, Diagnostic243 days
IKTElectrode, Needle, Diagnostic Electromyograph215 days
OMAAmplitude-Integrated Electroencephalograph228 days

Showing the 25 they file in most, of 36.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Nihon Kohden America Inc had a recall?

openFDA lists 12 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-0267-2025Class IIOpen, ClassifiedDQA

    Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

  • Z-0268-2025Class IIOpen, ClassifiedDQA

    Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

  • Z-2025-2024Class IIOpen, ClassifiedMHX

    Due to software issue the device may give false "SpO2 Probe Failure" alarm

  • Z-0314-2025Class IIOpen, ClassifiedCCK

    Due to products being shipped/distributed to customers after the products expiration date had past.

  • Z-1162-2021Class IIOpen, ClassifiedDRG

    Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Showing the 5 most recently initiated of 12.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Nihon Kohden America Inc cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXGWQ153
K120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT POMA28
K092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMOMA323
K083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PCCK101
K083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYMHX48
K082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIESMHX64
K071969SEN-4100 ELECTRIC STIMULATORGWF447
K080546NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200AOLT183
K073550PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATIONMHX101
K080342NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIESMHX18

Source: openFDA device/510k · retrieved

Where is Nihon Kohden America Inc registered?

FDA lists 1 registered establishment for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Nihon Kohden America Inc files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.