Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nova Biomedical Corporation — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
456 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026-01-21 | 272 | 0 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026-01-09 | 179 | 0 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-22 | 931 | 0 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-19 | 881 | 0 |
| K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2024-02-23 | 226 | 1 |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023-09-29 | 456 | 0 |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022-10-18 | 683 | 0 |
| K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-04-14 | 55 | 2 |
| K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-04-06 | 69 | 0 |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-03-13 | 30 | 0 |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-01-24 | 60 | 0 |
| K191626 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019-08-16 | 59 | 0 |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019-07-19 | 58 | 0 |
| K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-12-13 | 87 | 0 |
| K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-12-13 | 87 | 0 |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-09-26 | 231 | 0 |
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-08-23 | 212 | 0 |
| K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-08-15 | 180 | 0 |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-07-17 | 215 | 0 |
| K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018-07-12 | 84 | 0 |
| K170464 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | 2017-11-07 | 265 | 0 |
| K171059 | Nova StatSensor Creatinine Hospital Meter System | Nova Biomedical Corporation | 2017-05-26 | 46 | 0 |
| K160990 | Nova Max Uric Acid Monitoring System | Nova Biomedical Corporation | 2017-04-11 | 368 | 0 |
| K163490 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2017-01-06 | 25 | 0 |
| K161856 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2016-11-15 | 132 | 0 |
| K160156 | StatStrip Xpress Blood Glucose Monitoring System | Nova Biomedical Corporation | 2016-06-23 | 153 | 0 |
| K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2016-01-27 | 110 | 0 |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | 2015-09-10 | 55 | 0 |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME A | Nova Biomedical Corporation | 2015-05-29 | 318 | 0 |
| K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2015-05-20 | 86 | 0 |
| K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015-05-06 | 90 | 0 |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Cali | Nova Biomedical Corporation | 2014-10-17 | 66 | 0 |
| K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2014-09-24 | 441 | 0 |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | Nova Biomedical Corporation | 2014-03-25 | 287 | 0 |
| K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCO | Nova Biomedical Corporation | 2013-10-17 | 189 | 0 |
| K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR | Nova Biomedical Corporation | 2013-04-04 | 212 | 0 |
| K122435 | NOVA ONE BLOOD GLUCOSE MONITOR | Nova Biomedical Corporation | 2012-12-20 | 132 | 0 |
| K112638 | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCO | Nova Biomedical Corporation | 2012-03-09 | 182 | 0 |
| K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM | Nova Biomedical Corporation | 2012-01-05 | 93 | 0 |
| K110648 | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM | Nova Biomedical Corporation | 2011-08-29 | 178 | 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