Nova Biomedical Corp.: FDA clearances and approvals
Nova Biomedical Corp. has 129 FDA 510(k) clearances (first 1977, latest 2026), across 32 product codes in 2 review panels. Median 510(k) review time: 78 days. Since 2017 its median was 180 days, against 232 days for all cleared 510(k)s in the same product codes. openFDA lists 41 product recalls by a recalling firm named Nova Biomedical Corp. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 132 |
| 2013 | 2 | 200 |
| 2014 | 3 | 287 |
| 2015 | 4 | 88 |
| 2016 | 3 | 132 |
| 2017 | 4 | 156 |
| 2018 | 7 | 180 |
| 2019 | 2 | 58 |
| 2020 | 4 | 58 |
| 2021 | 0 | — |
| 2022 | 1 | 683 |
| 2023 | 1 | 456 |
| 2024 | 3 | 881 |
| 2025 | 0 | — |
| 2026 | 2 | 226 |
Review time against the same product codes
Since 2017, Nova Biomedical Corp.'s cleared 510(k)s took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 28 | 28 |
| JGS | Electrode, Ion Specific, Sodium | 21 | 21 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 10 | 10 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 | 8 |
| CGA | Glucose Oxidase, Glucose | 7 | 7 |
| JFP | Electrode, Ion Specific, Calcium | 6 | 6 |
| NBW | System, Test, Blood Glucose, Over The Counter | 6 | 6 |
| CEM | Electrode, Ion Specific, Potassium | 4 | 4 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 3 | 3 |
| GKF | Instrument, Hematocrit, Automated | 3 | 3 |
Plus 22 more product codes.
Review panels
- Clinical Chemistry (118)
- Hematology (11)
Most recent Nova Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | SHB | 2026-01-21 | 272 |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 2026-01-09 | 179 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | LCP | 2024-11-22 | 931 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | CGX | 2024-11-19 | 881 |
| K232075 | StatStrip Glucose Hospital Meter System | PZI | 2024-02-23 | 226 |
| K221900 | Stat Profile Prime Plus Analyzer System | CHL | 2023-09-29 | 456 |
| K203549 | Nova Primary Glucose Analyzer System | CGA | 2022-10-18 | 683 |
| K200403 | Stat Profile Prime Plus Analyzer System | JGS | 2020-04-14 | 55 |
| K200204 | Stat Profile Prime Plus Analyzer System | GGZ | 2020-04-06 | 69 |
| K200349 | Stat Profile Prime Plus Analyzer System | CGA | 2020-03-13 | 30 |
119 earlier clearances. See the full list in Caduvo.
Recalls
41 product recalls in 15 recall events; 10 initiated in the last five years. Most recent: 2026-07-29.
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.
Device clinical trials
Nova Biomedical Corp. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04035044: Study of the Analytical Performance of ALLEGRO™ Instrument (Completed, started 2017-06-01)
Frequently asked questions
How many FDA 510(k) clearances does Nova Biomedical Corp. have?
Nova Biomedical Corp. has 129 FDA 510(k) clearances (first 1977, latest 2026), across 32 product codes in 2 review panels.
How long does FDA take to clear Nova Biomedical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Nova Biomedical Corp.'s cleared 510(k)s is 78 days. Since 2017: 180 days, versus 232 days for all cleared 510(k)s in the same product codes.
What devices does Nova Biomedical Corp. make?
Its most frequent FDA product codes are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 28); JGS (Electrode, Ion Specific, Sodium, 21); PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing, 10).
Has Nova Biomedical Corp. had device recalls?
openFDA lists 41 product recalls in 15 recall events by a recalling firm whose name matches Nova Biomedical Corp; the most recent began 2026-07-29. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 129 Nova Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Nova Biomedical Corp.'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.