Embla Systems: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Embla Systems” (first 2008, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 188 days. Since 2017 the median was 276 days, against 156 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 | 0 | — |
| 2013 | 1 | 188 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 169 |
| 2017 | 2 | 88 |
| 2018 | 0 | — |
| 2019 | 2 | 538 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Embla Systems took a median 276 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 5 | 5 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Anesthesiology (5)
- Neurology (4)
Most recent Embla Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant | MNR | 2019-09-27 | 633 |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | MNR | 2019-03-01 | 442 |
| K172703 | Disposable Snap Electrode | GXY | 2017-11-13 | 67 |
| K163617 | REMbrandt | OLZ | 2017-04-11 | 110 |
| K162140 | RemLogic | OLZ | 2016-12-01 | 122 |
| K153353 | SANDMAN ELITE | OLZ | 2016-06-23 | 216 |
| K122516 | EMBLETTA MPR | MNR | 2013-02-21 | 188 |
| K111742 | MDRIVE | MNR | 2011-08-31 | 71 |
| K073682 | EMBLETTA GOLD | MNR | 2008-08-08 | 224 |
Recalls
openFDA lists no recalls under a recalling firm named Embla Systems.
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 Embla Systems?
FDA lists 9 510(k) clearances under the applicant name “Embla Systems” (first 2008, latest 2019), across 3 product codes in 2 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 Embla Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Embla Systems is 188 days. Since 2017: 276 days, versus 156 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Embla Systems?
The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 5); OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph, 3); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 9 Embla Systems clearances with predicates and recalls
- Run predicate analysis for product code MNR, Embla Systems'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.