InspireMD, Ltd.: FDA clearances and approvals
InspireMD, Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel. openFDA lists 6 product recalls by a recalling firm named InspireMD, Ltd. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov. It files with the SEC as InspireMD, Inc. (NSPR).
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NIM | Stent, Carotid | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240029 | PMA | CGuard Prime Carotid Stent System | 2025-06-23 |
Recalls
6 product recalls in 1 recall events; 6 initiated in the last five years. Most recent: 2026-05-01.
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.
Device clinical trials
InspireMD, Ltd. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06653387: A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach (Recruiting, started 2024-11-20)
- NCT04900844: Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (Active not recruiting, started 2021-07-01)
- NCT01368471: Safety and Efficacy Study of MGuard Stent After a Heart Attack (Completed, started 2011-06)
- NCT00922337: The Israeli MGuard Registry (Completed, started 2009-07)
SEC filings
InspireMD, Inc. (NSPR): EDGAR filings, CIK 1433607. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does InspireMD, Ltd. have?
InspireMD, Ltd. has 0 FDA 510(k) clearances, plus 1 PMA decision, across 1 product code in 1 review panel.
What devices does InspireMD, Ltd. make?
Its most frequent FDA product codes are NIM (Stent, Carotid, 1).
Has InspireMD, Ltd. had device recalls?
openFDA lists 6 product recalls in 1 recall event by a recalling firm whose name matches InspireMD, Ltd; the most recent began 2026-05-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 InspireMD, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NIM, InspireMD, Ltd.'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.