Nonin Medical, Inc.: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Nonin Medical, Inc.” (first 1986, latest 2024), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 119 days. Since 2017 the median was 252 days, against 184 days for all cleared 510(k)s in the same product codes. 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 | 2 | 199 |
| 2013 | 1 | 152 |
| 2014 | 2 | 151 |
| 2015 | 1 | 101 |
| 2016 | 2 | 227 |
| 2017 | 0 | — |
| 2018 | 1 | 252 |
| 2019 | 2 | 134 |
| 2020 | 1 | 258 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 1279 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nonin Medical, Inc. took a median 252 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 42 | 42 |
| MUD | Oximeter, Tissue Saturation | 5 | 5 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| OLK | Pulse Oximeter For Over-The-Counter Use | 1 | 1 |
Review panels
Most recent Nonin Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | OLK | 2024-11-13 | 1279 |
| K192900 | H500 Multi-Sensing Oximetry System | DQA | 2020-06-29 | 258 |
| K191403 | Pulse Oximeter | DQA | 2019-12-20 | 210 |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | MUD | 2019-05-02 | 58 |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | DQA | 2018-05-11 | 252 |
| K160231 | Model X-100C CO-Met Oximetry System | DQA | 2016-12-23 | 326 |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | DQA | 2016-08-05 | 128 |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | MUD | 2015-08-27 | 101 |
| K140785 | PULSE OXIMETER | DQA | 2014-07-07 | 98 |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | DQA | 2014-02-21 | 204 |
40 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2016-09-29.
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.
Device clinical trials
An industry sponsor named Nonin Medical, Inc. is the lead sponsor of 9 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03869840: Accuracy of Detection of Methemoglobin With Pulse Oximetry (Completed, started 2019-03-26)
- NCT03592914: Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients (Completed, started 2018-07-31)
- NCT03223870: Respiratory Rate Accuracy - Healthy Adults (Completed, started 2017-07-11)
- NCT03030833: Dysfunctional Hemoglobin Pulse Oximetry (Completed, started 2017-02-06)
- NCT02950701: Suspected Cases of Carbon Monoxide Poisoning (Completed, started 2016-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nonin Medical, Inc.?
FDA lists 50 510(k) clearances under the applicant name “Nonin Medical, Inc.” (first 1986, latest 2024), across 5 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 Nonin Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nonin Medical, Inc. is 119 days. Since 2017: 252 days, versus 184 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nonin Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 42); MUD (Oximeter, Tissue Saturation, 5); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1).
Next steps
- See all 50 Nonin Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Nonin Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.