I-Sens, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “I-Sens, Inc.” (first 2008, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 122 days. Since 2017 the median was 154 days, against 177 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 | 4 | 88 |
| 2013 | 4 | 104 |
| 2014 | 0 | — |
| 2015 | 1 | 98 |
| 2016 | 1 | 274 |
| 2017 | 2 | 220 |
| 2018 | 3 | 171 |
| 2019 | 1 | 120 |
| 2020 | 3 | 92 |
| 2021 | 1 | 496 |
| 2022 | 1 | 82 |
| 2023 | 1 | 157 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name I-Sens, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 177 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 21 | 21 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 2 | 2 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 | 1 |
Review panels
Most recent I-Sens, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | NBW | 2023-08-10 | 157 |
| K222656 | LDE4 Lancing Device | QRL | 2022-11-23 | 82 |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | NBW | 2021-10-05 | 496 |
| K201551 | KetoSens BT Blood B-Ketone Monitoring System | JIN | 2020-09-09 | 92 |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | NBW | 2020-01-24 | 112 |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | NBW | 2020-01-17 | 25 |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | NBW | 2019-12-13 | 120 |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | NBW | 2018-11-01 | 171 |
| K180866 | CareSens S Fit Blood Glucose Monitoring System | NBW | 2018-08-31 | 151 |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | JIN | 2018-04-13 | 422 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named I-Sens, 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.
Device clinical trials
An industry sponsor named I-Sens, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07296276: Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM (Recruiting, started 2026-02-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under I-Sens, Inc.?
FDA lists 27 510(k) clearances under the applicant name “I-Sens, Inc.” (first 2008, latest 2023), across 4 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 I-Sens, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I-Sens, Inc. is 122 days. Since 2017: 154 days, versus 177 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under I-Sens, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 21); CGA (Glucose Oxidase, Glucose, 3); JIN (Nitroprusside, Ketones (Urinary, Non-Quant.), 2).
Next steps
- See all 27 I-Sens, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, I-Sens, 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.