Nihon Kohden America, Inc.: FDA clearances and approvals
Nihon Kohden America, Inc. has 166 FDA 510(k) clearances (first 1979, latest 2012), across 37 product codes in 6 review panels. Median 510(k) review time: 94 days. openFDA lists 12 product recalls by a recalling firm named Nihon Kohden America, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 90 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 21 | 21 |
| DSI | Detector And Alarm, Arrhythmia | 18 | 18 |
| GWQ | Full-Montage Standard Electroencephalograph | 15 | 15 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 11 | 11 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 10 | 10 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 9 | 9 |
| OLV | Standard Polysomnograph With Electroencephalograph | 9 | 9 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 8 | 8 |
| GWF | Stimulator, Electrical, Evoked Response | 7 | 7 |
| DQA | Oximeter | 6 | 6 |
Plus 27 more product codes.
Review panels
- Cardiovascular (90)
- Neurology (48)
- Anesthesiology (21)
- Gastroenterology and Urology (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
Most recent Nihon Kohden America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113117 | NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX | GWQ | 2012-03-22 | 153 |
| K120485 | NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P | OMA | 2012-03-16 | 28 |
| K092573 | NIHON KOHDEN QP-160AK EEG TREND PROGRAM | OMA | 2010-07-09 | 323 |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | CCK | 2009-03-02 | 101 |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY | MHX | 2008-12-24 | 48 |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | MHX | 2008-11-26 | 64 |
| K071969 | SEN-4100 ELECTRIC STIMULATOR | GWF | 2008-10-06 | 447 |
| K080546 | NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A | OLT | 2008-08-29 | 183 |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | MHX | 2008-03-28 | 101 |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | MHX | 2008-02-26 | 18 |
156 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 11 recall events; 4 initiated in the last five years. Most recent: 2024-09-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Nihon Kohden America, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Nihon Kohden America, Inc. have?
Nihon Kohden America, Inc. has 166 FDA 510(k) clearances (first 1979, latest 2012), across 37 product codes in 6 review panels.
How long does FDA take to clear Nihon Kohden America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nihon Kohden America, Inc.'s cleared 510(k)s is 94 days.
What devices does Nihon Kohden America, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 21); DSI (Detector And Alarm, Arrhythmia, 18); GWQ (Full-Montage Standard Electroencephalograph, 15).
Has Nihon Kohden America, Inc. had device recalls?
openFDA lists 12 product recalls in 11 recall events by a recalling firm whose name matches Nihon Kohden America, Inc; the most recent began 2024-09-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 166 Nihon Kohden America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Nihon Kohden America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.