Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nova Biomedical Corp. — Predicate Candidate Screening
89 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
138 days90th percentile
89clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTAT | Nova Biomedical Corp. | 2011-08-17 | 532 | 0 |
| K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIG | Nova Biomedical Corp. | 2010-08-27 | 78 | 0 |
| K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOV | Nova Biomedical Corp. | 2010-01-15 | 233 | 10 |
| K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corp. | 2007-07-11 | 97 | 1 |
| K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 | Nova Biomedical Corp. | 2007-06-13 | 138 | 0 |
| K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS | Nova Biomedical Corp. | 2007-05-07 | 119 | 5 |
| K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM | Nova Biomedical Corp. | 2007-01-24 | 29 | 4 |
| K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ | Nova Biomedical Corp. | 2006-11-01 | 126 | 0 |
| K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOL | Nova Biomedical Corp. | 2006-04-28 | 77 | 3 |
| K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS | Nova Biomedical Corp. | 2004-05-07 | 17 | 0 |
| K033433 | NOVA GLUCOSE CONTROL SOLUTIONS | Nova Biomedical Corp. | 2004-01-02 | 66 | 0 |
| K023567 | STAT PROFILE PHOX PLUS L ANALYZER | Nova Biomedical Corp. | 2002-12-20 | 58 | 0 |
| K022746 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | Nova Biomedical Corp. | 2002-11-22 | 95 | 4 |
| K021713 | STAT PROFILE PHOX PLUS C ANALYZER | Nova Biomedical Corp. | 2002-07-25 | 63 | 0 |
| K020297 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | Nova Biomedical Corp. | 2002-06-10 | 133 | 1 |
| K014295 | STAT PROFILE PHOX ANALYZER | Nova Biomedical Corp. | 2002-02-28 | 62 | 0 |
| K013729 | STAT PROFILE PHOX BASIC ANALYZER | Nova Biomedical Corp. | 2002-01-15 | 67 | 0 |
| K012058 | STAT PROFILE PHOX PLUS L ANALYZER | Nova Biomedical Corp. | 2001-08-20 | 49 | 0 |
| K002613 | MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER | Nova Biomedical Corp. | 2000-10-19 | 58 | 0 |
| K001761 | STATLYTE NA/K/CL/LI ANALYZER | Nova Biomedical Corp. | 2000-08-07 | 59 | 0 |
| K000895 | STAT PROFILE PHOX PLUS ANALYZER | Nova Biomedical Corp. | 2000-04-17 | 28 | 0 |
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CON | Nova Biomedical Corp. | 1999-12-02 | 77 | 0 |
| K991727 | STAT PROFILE M7 ANALYZER | Nova Biomedical Corp. | 1999-07-16 | 57 | 0 |
| K982277 | MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K98099 | Nova Biomedical Corp. | 1998-07-22 | 23 | 0 |
| K981426 | STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS | Nova Biomedical Corp. | 1998-05-12 | 26 | 0 |
| K981425 | STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS | Nova Biomedical Corp. | 1998-05-12 | 26 | 0 |
| K981427 | STAT PROFILE M ANALYZER | Nova Biomedical Corp. | 1998-05-12 | 26 | 1 |
| K980991 | NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER | Nova Biomedical Corp. | 1998-04-15 | 29 | 0 |
| K970710 | STAT PROFILE ULTRA M ANALYZER | Nova Biomedical Corp. | 1997-05-09 | 72 | 0 |
| K962982 | NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT | Nova Biomedical Corp. | 1996-08-23 | 22 | 0 |
| K963005 | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) | Nova Biomedical Corp. | 1996-08-23 | 21 | 0 |
| K962997 | NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 | Nova Biomedical Corp. | 1996-08-15 | 13 | 0 |
| K961938 | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS | Nova Biomedical Corp. | 1996-06-28 | 39 | 0 |
| K955013 | NOVA CO-OXIMETER ANALYZER | Nova Biomedical Corp. | 1996-04-25 | 176 | 0 |
| K960120 | STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS | Nova Biomedical Corp. | 1996-03-11 | 60 | 0 |
| K955260 | NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION | Nova Biomedical Corp. | 1996-02-02 | 79 | 0 |
| K955264 | NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2 | Nova Biomedical Corp. | 1996-02-02 | 79 | 0 |
| K955252 | NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4 | Nova Biomedical Corp. | 1996-02-02 | 79 | 0 |
| K954711 | STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) | Nova Biomedical Corp. | 1995-11-30 | 63 | 0 |
| K952477 | STAT PROFILE ULTRA BLOOD GAS CONTROLS | Nova Biomedical Corp. | 1995-07-06 | 37 | 0 |
| K936066 | STAT PROFILE PLUS 9 ANALYZER | Nova Biomedical Corp. | 1995-03-09 | 443 | 0 |
| K936203 | STAT PROFILE PLUS 10 ANALYZER | Nova Biomedical Corp. | 1995-03-09 | 443 | 0 |
| K945584 | NOVA 16 ANALYZER | Nova Biomedical Corp. | 1995-02-08 | 86 | 0 |
| K943643 | STAT PROFILE ULTRA 11 ANALYZER | Nova Biomedical Corp. | 1994-12-29 | 155 | 0 |
| K931373 | ANALYZER: STAT PROFILE PLUS 10 ANALYZER | Nova Biomedical Corp. | 1993-06-15 | 89 | 0 |
| K924497 | STAT PROFILE 9 ANALYZER | Nova Biomedical Corp. | 1993-02-23 | 172 | 0 |
| K924547 | NOVA 8 CRT ANALYZER | Nova Biomedical Corp. | 1993-01-28 | 141 | 0 |
| K924864 | NOVA 13 ANALYZER, MODIFICATION | Nova Biomedical Corp. | 1992-11-06 | 56 | 0 |
| K924743 | NOVA 12 ANALYZER, MODIFICATION | Nova Biomedical Corp. | 1992-11-06 | 53 | 0 |
| K922943 | NOVA NA/K/CL/LI MODULE | Nova Biomedical Corp. | 1992-10-13 | 117 | 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