Nikomed U.S.A., Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Nikomed U.S.A., Inc.” (first 1987, latest 2003), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 276 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 12 | 12 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
Most recent Nikomed U.S.A., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022909 | NIKOMED TRACE 1 ECG ELECTRODES | DRX | 2003-01-09 | 128 |
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | HAM | 2000-02-04 | 24 |
| K950473 | DISPOSABLE ECG MONITORING ELECTRODE | DRX | 1995-12-12 | 312 |
| K950475 | DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 | DRX | 1995-11-14 | 284 |
| K950472 | DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM | DRX | 1995-11-14 | 284 |
| K950480 | DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM | DRX | 1995-11-06 | 276 |
| K950478 | DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM | DRX | 1995-11-06 | 276 |
| K950477 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM | DRX | 1995-11-06 | 276 |
| K950474 | DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM | DRX | 1995-11-06 | 276 |
| K950471 | DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM | DRX | 1995-11-06 | 276 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nikomed U.S.A., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nikomed U.S.A., Inc.?
FDA lists 15 510(k) clearances under the applicant name “Nikomed U.S.A., Inc.” (first 1987, latest 2003), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nikomed U.S.A., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nikomed U.S.A., Inc. is 276 days.
Which FDA product codes appear under Nikomed U.S.A., Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 12); CBH (Device, Fixation, Tracheal Tube, 1); HAM (Apparatus, Electrosurgical, 1).
Next steps
- See all 15 Nikomed U.S.A., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Nikomed U.S.A., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.