Helix Opco, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Helix Opco, LLC” (first 2020, latest 2020), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 509 days. 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 |
|---|---|---|
| 2020 | 1 | 509 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Helix Opco, LLC took a median 509 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 265 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PTA | Genetic Variant Detection And Health Risk Assessment System | 1 | 1 |
| QNC | Whole Exome Sequencing Constituent Device | 1 | 0 |
Review panels
- Immunology (1)
- Pathology (1)
Most recent Helix Opco, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimers disease | PTA | 2020-12-23 | 509 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN190035 | De Novo | Whole Exome Sequencing Constituent Device | 2020-12-23 |
Recalls
openFDA lists no recalls under a recalling firm named Helix Opco, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Helix Medical, Inc. (18 510(k)s)
- Helix Diagnostics, Inc. (15 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Helix Opco, LLC?
FDA lists 1 510(k) clearance under the applicant name “Helix Opco, LLC” (first 2020, latest 2020), plus 1 De Novo decision, across 2 product codes in 2 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 Helix Opco, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Helix Opco, LLC is 509 days.
Which FDA product codes appear under Helix Opco, LLC?
The most frequent FDA product codes under this applicant name are PTA (Genetic Variant Detection And Health Risk Assessment System, 1); QNC (Whole Exome Sequencing Constituent Device, 1).
Next steps
- See all 1 Helix Opco, LLC clearances with predicates and recalls
- Run predicate analysis for product code PTA, Helix Opco, LLC'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.