Sd Biosensor: FDA clearances and approvals
Sd Biosensor has 6 FDA 510(k) clearances (first 2014, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time: 488 days. openFDA lists 2 product recalls by a recalling firm named Sd Biosensor.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 429 |
| 2015 | 3 | 547 |
| 2016 | 1 | 233 |
| 2017 | 1 | 623 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sd Biosensor's cleared 510(k)s took a median 623 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 5 | 5 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (5)
- Hematology (1)
Most recent Sd Biosensor 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System | NBW | 2017-10-17 | 623 |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System | NBW | 2016-06-24 | 233 |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System | NBW | 2015-11-24 | 195 |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | LCP | 2015-09-30 | 547 |
| K132929 | SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2015-08-05 | 687 |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-01-17 | 429 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2023-03-31.
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 Sd Biosensor have?
Sd Biosensor has 6 FDA 510(k) clearances (first 2014, latest 2017), across 2 product codes in 2 review panels.
How long does FDA take to clear Sd Biosensor's 510(k)s?
The median time from FDA receipt to decision across Sd Biosensor's cleared 510(k)s is 488 days.
What devices does Sd Biosensor make?
Its most frequent FDA product codes are NBW (System, Test, Blood Glucose, Over The Counter, 5); LCP (Assay, Glycosylated Hemoglobin, 1).
Has Sd Biosensor had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Sd Biosensor; the most recent began 2023-03-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Sd Biosensor clearances with predicates and recalls
- Run predicate analysis for product code NBW, Sd Biosensor'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.