Healgen Scientific,, LLC: FDA clearances and approvals
Healgen Scientific,, LLC has 27 FDA 510(k) clearances (first 2012, latest 2026), across 18 product codes in 4 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 101 days, against 134 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Healgen Scientific,, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 279 |
| 2013 | 1 | 128 |
| 2014 | 3 | 62 |
| 2015 | 7 | 56 |
| 2016 | 1 | 159 |
| 2017 | 1 | 216 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 210 |
| 2023 | 2 | 113 |
| 2024 | 4 | 42 |
| 2025 | 3 | 50 |
| 2026 | 3 | 112 |
Review time against the same product codes
Since 2017, Healgen Scientific,, LLC's cleared 510(k)s took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 4 | 4 |
| NGL | Test, Opiates, Over The Counter | 4 | 4 |
| DJG | Enzyme Immunoassay, Opiates | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| JIO | Blood, Occult, Colorimetric, In Urine | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Toxicology (20)
- Microbiology (3)
- Clinical Chemistry (2)
- Hematology (2)
Most recent Healgen Scientific,, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | QYT | 2026-04-13 | 90 |
| K253705 | Healgen® Accurate Oral Fluid Drug Test | DJC | 2026-03-16 | 112 |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | NFW | 2026-02-12 | 185 |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2025-12-23 | 36 |
| K251800 | Healgen® URS Test Strips | JMT | 2025-12-23 | 194 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | DJG | 2025-08-15 | 50 |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | NGL | 2024-12-17 | 49 |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | NGL | 2024-05-13 | 35 |
| K232377 | Healgen Rapid COVID-19 Antigen Test | QVF | 2024-04-19 | 255 |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | NGL | 2024-04-12 | 31 |
17 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-08-22.
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 Healgen Scientific,, LLC have?
Healgen Scientific,, LLC has 27 FDA 510(k) clearances (first 2012, latest 2026), across 18 product codes in 4 review panels.
How long does FDA take to clear Healgen Scientific,, LLC's 510(k)s?
The median time from FDA receipt to decision across Healgen Scientific,, LLC's cleared 510(k)s is 90 days. Since 2017: 101 days, versus 134 days for all cleared 510(k)s in the same product codes.
What devices does Healgen Scientific,, LLC make?
Its most frequent FDA product codes are JXM (Enzyme Immunoassay, Benzodiazepine, 4); NGL (Test, Opiates, Over The Counter, 4); DJG (Enzyme Immunoassay, Opiates, 3).
Has Healgen Scientific,, LLC had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Healgen Scientific,, LLC; the most recent began 2024-08-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 27 Healgen Scientific,, LLC clearances with predicates and recalls
- Run predicate analysis for product code JXM, Healgen Scientific,, LLC'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.