Medisense, Inc.: FDA clearances and approvals
Medisense, Inc. has 15 FDA 510(k) clearances (first 1990, latest 1999), across 5 product codes in 3 review panels. Median 510(k) review time: 95 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 11 | 11 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| LDP | Colorimetry, Acetaminophen | 1 | 1 |
Review panels
- Clinical Chemistry (13)
- Hematology (1)
- Clinical Toxicology (1)
Most recent Medisense, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983504 | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST | CGA | 1999-07-09 | 276 |
| K982303 | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST | CGA | 1998-12-08 | 160 |
| K983253 | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT | LCP | 1998-11-20 | 65 |
| K971812 | PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP | CGA | 1997-08-08 | 84 |
| K963676 | PRECISION G BLOOD GLUCOSE TESTING SYSTEM | CGA | 1997-02-20 | 160 |
| K962295 | PRECISION QID BLOOD GLUCOSE TEST STRIP | CGA | 1996-07-26 | 71 |
| K961337 | EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM | CGA | 1996-06-21 | 74 |
| K952279 | PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM | CGA | 1995-06-14 | 64 |
| K945887 | PRECISION Q I D BLOOD GLUCOSE TEST STRIPS | CGA | 1995-03-23 | 112 |
| K944195 | QUICKPRO BLOOD GLUCOSE TESTING SYSTEM | CGA | 1995-03-23 | 206 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medisense, Inc..
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 Medisense, Inc. have?
Medisense, Inc. has 15 FDA 510(k) clearances (first 1990, latest 1999), across 5 product codes in 3 review panels.
How long does FDA take to clear Medisense, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medisense, Inc.'s cleared 510(k)s is 95 days.
What devices does Medisense, Inc. make?
Its most frequent FDA product codes are CGA (Glucose Oxidase, Glucose, 11); CEM (Electrode, Ion Specific, Potassium, 1); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1).
Has Medisense, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medisense, Inc. Related entities may recall under other names.
Next steps
- See all 15 Medisense, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Medisense, 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.