Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hypoguard USA, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
256 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053079 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | Hypoguard USA, Inc. | 2006-03-28 | 146 | 0 |
| K051514 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 | Hypoguard USA, Inc. | 2005-10-04 | 118 | 0 |
| K041881 | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 41 | Hypoguard USA, Inc. | 2005-03-25 | 256 | 0 |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK) | Hypoguard USA, Inc. | 2004-03-02 | 82 | 0 |
| K031388 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING S | Hypoguard USA, Inc. | 2003-05-22 | 20 | 0 |
| K024347 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | Hypoguard USA, Inc. | 2003-03-28 | 88 | 0 |
| K022545 | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 | Hypoguard USA, Inc. | 2002-10-11 | 71 | 0 |
| K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | Hypoguard USA, Inc. | 2002-02-12 | 29 | 2 |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIAS | Hypoguard USA, Inc. | 2001-09-11 | 162 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda