Hmd Biomedical, Inc.: FDA clearances and approvals
Hmd Biomedical, Inc. has 11 FDA 510(k) clearances (first 2003, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time: 276 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 262 |
| 2013 | 1 | 276 |
| 2014 | 1 | 511 |
| 2015 | 1 | 477 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 244 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 406 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hmd Biomedical, Inc.'s cleared 510(k)s took a median 325 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 8 | 8 |
| LFR | Glucose Dehydrogenase, Glucose | 3 | 3 |
Review panels
- Clinical Chemistry (11)
Most recent Hmd Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212248 | GlucoLeader Enhance 2 Blood Glucose Monitoring System | NBW | 2022-08-29 | 406 |
| K182428 | GlucoLeader Enhance Blood Glucose Monitoring System | NBW | 2019-05-08 | 244 |
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30 | NBW | 2015-05-14 | 477 |
| K131173 | FIA Blood Glucose Monitoring System (G2) | NBW | 2014-09-18 | 511 |
| K121433 | GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS | LFR | 2013-02-14 | 276 |
| K113314 | PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | LFR | 2012-11-09 | 366 |
| K120064 | TEST, BLOOD GLUCOSE SYSTEM | NBW | 2012-09-05 | 240 |
| K113307 | GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM | LFR | 2012-07-27 | 262 |
| K072369 | EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2008-03-21 | 211 |
| K032985 | GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM | NBW | 2003-10-21 | 27 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hmd Biomedical, 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 Hmd Biomedical, Inc. have?
Hmd Biomedical, Inc. has 11 FDA 510(k) clearances (first 2003, latest 2022), across 2 product codes in 1 review panel.
How long does FDA take to clear Hmd Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hmd Biomedical, Inc.'s cleared 510(k)s is 276 days.
What devices does Hmd Biomedical, Inc. make?
Its most frequent FDA product codes are NBW (System, Test, Blood Glucose, Over The Counter, 8); LFR (Glucose Dehydrogenase, Glucose, 3).
Has Hmd Biomedical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hmd Biomedical, Inc. Related entities may recall under other names.
Next steps
- See all 11 Hmd Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Hmd Biomedical, 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.