Avl Scientific Corp.: FDA clearances and approvals
Avl Scientific Corp. has 33 FDA 510(k) clearances (first 1982, latest 2000), across 13 product codes in 4 review panels. Median 510(k) review time: 56 days.
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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 12 | 12 |
| JFP | Electrode, Ion Specific, Calcium | 4 | 4 |
| CEM | Electrode, Ion Specific, Potassium | 3 | 3 |
| JGS | Electrode, Ion Specific, Sodium | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| GKR | System, Hemoglobin, Automated | 1 | 1 |
| GLY | Oximeter To Measure Hemoglobin | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (29)
- Hematology (2)
- General Hospital (1)
- Neurology (1)
Most recent Avl Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | JJY | 2000-06-19 | 24 |
| K000103 | AVL OPTI R ANALYZER | CHL | 2000-03-20 | 67 |
| K993837 | AVL OPTI CRITICAL CARE ANALYZER | CGA | 1999-12-16 | 34 |
| K990092 | AVL OMNI MODULAR ANALYZER | CHL | 1999-01-29 | 18 |
| K984299 | AVL OPTI CRITICAL CARE ANALYZER | JFP | 1998-12-11 | 10 |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | CEM | 1998-02-24 | 64 |
| K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | JJY | 1998-01-22 | 29 |
| K972733 | AVL OMNI ANALYZER | CGA | 1997-09-09 | 50 |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | JFP | 1997-08-20 | 35 |
| K963964 | AVL COMPACT 3 PH/BLOOD GAS ANALYZER | CHL | 1996-11-29 | 58 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Avl Scientific Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does Avl Scientific Corp. have?
Avl Scientific Corp. has 33 FDA 510(k) clearances (first 1982, latest 2000), across 13 product codes in 4 review panels.
How long does FDA take to clear Avl Scientific Corp.'s 510(k)s?
The median time from FDA receipt to decision across Avl Scientific Corp.'s cleared 510(k)s is 56 days.
What devices does Avl Scientific Corp. make?
Its most frequent FDA product codes are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 12); JFP (Electrode, Ion Specific, Calcium, 4); CEM (Electrode, Ion Specific, Potassium, 3).
Has Avl Scientific Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Avl Scientific Corp. Related entities may recall under other names.
Next steps
- See all 33 Avl Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code CHL, Avl Scientific 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.