Element Science, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Element Science, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVK | Wearable Automated External Defibrillator | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230022 | PMA | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | 2025-04-30 |
Recalls
openFDA lists no recalls under a recalling firm named Element Science, Inc..
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.
Device clinical trials
An industry sponsor named Element Science, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05201495: The Jewel IDE Study (Completed, started 2022-01-12)
- NCT05490459: Jewel Electrophysiology (EP) Lab Study (Completed, started 2018-11-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under Element Science, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Element Science, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Element Science, Inc.?
The most frequent FDA product codes under this applicant name are MVK (Wearable Automated External Defibrillator, 1).
Next steps
- See all 0 Element Science, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVK, Element Science, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.