Hypoguard USA, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Hypoguard USA, Inc.” (first 2001, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. 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 | 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 | 5 | 5 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | 2 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 2 |
Review panels
Most recent Hypoguard USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053079 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | CGA | 2006-03-28 | 146 |
| K051514 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 | NBW | 2005-10-04 | 118 |
| K041881 | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 | CGA | 2005-03-25 | 256 |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) | JIL | 2004-03-02 | 82 |
| K031388 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2003-05-22 | 20 |
| K024347 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2003-03-28 | 88 |
| K022545 | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 | NBW | 2002-10-11 | 71 |
| K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2002-02-12 | 29 |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 | JIL | 2001-09-11 | 162 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-11-26.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hypoguard USA, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Hypoguard USA, Inc.” (first 2001, latest 2006), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hypoguard USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hypoguard USA, Inc. is 88 days.
Which FDA product codes appear under Hypoguard USA, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 5); JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative), 2); NBW (System, Test, Blood Glucose, Over The Counter, 2).
Next steps
- See all 9 Hypoguard USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Hypoguard USA, 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.