Home Diagnostics, Inc.: FDA clearances and approvals
Home Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1985, latest 2009), across 4 product codes in 2 review panels. Median 510(k) review time: 111 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 10 | 10 |
| CGA | Glucose Oxidase, Glucose | 9 | 9 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
Review panels
Most recent Home Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090495 | TRUEBALANCE BLOOD GLUCOSE SYSTEM | NBW | 2009-03-27 | 30 |
| K080641 | TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81 | NBW | 2008-08-19 | 166 |
| K080710 | TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81 | NBW | 2008-08-13 | 153 |
| K070593 | TRACKRECORD DATA MANAGEMENT SOFTWARE | NBW | 2007-05-07 | 66 |
| K060793 | ELEMENT BLOOD GLUCOSE TEST SYSTEM | NBW | 2006-07-25 | 124 |
| K051147 | SIDEKICK BLOOD GLUCOSE TEST SYSTEM | NBW | 2005-07-12 | 69 |
| K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM | JJX | 2004-08-19 | 16 |
| K040670 | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | NBW | 2004-03-25 | 10 |
| K032657 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) | NBW | 2004-03-24 | 209 |
| K030703 | TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS | NBW | 2003-07-11 | 127 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Home Diagnostics, 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 Home Diagnostics, Inc. have?
Home Diagnostics, Inc. has 22 FDA 510(k) clearances (first 1985, latest 2009), across 4 product codes in 2 review panels.
How long does FDA take to clear Home Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Home Diagnostics, Inc.'s cleared 510(k)s is 111 days.
What devices does Home Diagnostics, Inc. make?
Its most frequent FDA product codes are NBW (System, Test, Blood Glucose, Over The Counter, 10); CGA (Glucose Oxidase, Glucose, 9); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2).
Has Home Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Home Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 22 Home Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Home Diagnostics, 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.