Nidek Medical Products, Inc.: FDA clearances and approvals
Nidek Medical Products, Inc. has 12 FDA 510(k) clearances (first 1988, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time: 150 days. openFDA lists 9 product recalls by a recalling firm named Nidek Medical Products, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 85 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 224 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Nidek Medical Products, Inc.'s cleared 510(k)s took a median 224 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 218 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 7 | 7 |
| BZD | Ventilator, Non-Continuous (Respirator) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
Review panels
- Anesthesiology (12)
Most recent Nidek Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192693 | Nuvo Nano Portable Oxygen Concentrator | CAW | 2020-05-07 | 224 |
| K123738 | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD | CAW | 2013-02-28 | 85 |
| K093308 | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD | CAW | 2010-01-14 | 84 |
| K082566 | MARK 5 NUVO LITE OCSI AND STD | CAW | 2008-12-03 | 90 |
| K040892 | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 | CAW | 2004-04-29 | 23 |
| K032509 | MARK 5 NUVO (M5C5) | CAW | 2004-03-18 | 217 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | BTI | 2002-05-03 | 52 |
| K980551 | SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | BZD | 1998-11-17 | 278 |
| K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | BYE | 1997-01-23 | 211 |
| K952966 | CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | BZD | 1996-05-07 | 315 |
2 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-05-01.
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.
Frequently asked questions
How many FDA 510(k) clearances does Nidek Medical Products, Inc. have?
Nidek Medical Products, Inc. has 12 FDA 510(k) clearances (first 1988, latest 2020), across 5 product codes in 1 review panel.
How long does FDA take to clear Nidek Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nidek Medical Products, Inc.'s cleared 510(k)s is 150 days.
What devices does Nidek Medical Products, Inc. make?
Its most frequent FDA product codes are CAW (Generator, Oxygen, Portable, 7); BZD (Ventilator, Non-Continuous (Respirator), 2); BTI (Compressor, Air, Portable, 1).
Has Nidek Medical Products, Inc. had device recalls?
openFDA lists 9 product recalls in 1 recall event by a recalling firm whose name matches Nidek Medical Products, Inc; the most recent began 2012-05-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Nidek Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Nidek Medical Products, 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.