ACON Laboratories, Inc.: FDA filings under this applicant name
FDA lists 93 510(k) clearances under the applicant name “ACON Laboratories, Inc.” (first 1998, latest 2026), across 39 product codes in 7 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 133 days, against 168 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 142 |
| 2013 | 3 | 318 |
| 2014 | 2 | 174 |
| 2015 | 3 | 85 |
| 2016 | 1 | 29 |
| 2017 | 2 | 173 |
| 2018 | 3 | 42 |
| 2019 | 2 | 60 |
| 2020 | 1 | 262 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 227 |
| 2024 | 2 | 234 |
| 2025 | 4 | 158 |
| 2026 | 1 | 87 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ACON Laboratories, Inc. took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 13 | 13 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 10 | 10 |
| DJG | Enzyme Immunoassay, Opiates | 6 | 6 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 4 | 4 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 4 | 4 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 | 3 |
Plus 29 more product codes.
Review panels
- Clinical Chemistry (43)
- Clinical Toxicology (32)
- Microbiology (11)
- Hematology (3)
- General Hospital (2)
- Cardiovascular (1)
- General and Plastic Surgery (1)
Most recent ACON Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | SCA | 2026-07-10 | 87 |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | GTY | 2025-11-26 | 177 |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | SCA | 2025-10-22 | 138 |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | NBW | 2025-10-10 | 270 |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | SCA | 2025-05-10 | 89 |
| K232715 | Distinct® Digital Pregnancy Test | LCX | 2024-05-31 | 269 |
| K233373 | Flowflex® Plus COVID-19 Home Test | QYT | 2024-04-19 | 200 |
| K230828 | Flowflex COVID-19 Antigen Home Test | QYT | 2023-11-09 | 227 |
| K193318 | Distinct® Early Detection Pregnancy Test | LCX | 2020-08-20 | 262 |
| K192175 | On Call Express II Blood Glucose Monitoring System | NBW | 2019-10-17 | 66 |
83 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-06-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under ACON Laboratories, Inc.?
FDA lists 93 510(k) clearances under the applicant name “ACON Laboratories, Inc.” (first 1998, latest 2026), across 39 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by ACON Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ACON Laboratories, Inc. is 78 days. Since 2017: 133 days, versus 168 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ACON Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 13); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 10); DJG (Enzyme Immunoassay, Opiates, 6).
Next steps
- See all 93 ACON Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NBW, ACON Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.