Insightec, Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Insightec, Ltd.” (first 2021, latest 2023), plus 3 PMA decisions, across 3 product codes in 3 review panels. Median 510(k) review time under this name: 154 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 |
|---|---|---|
| 2021 | 1 | 137 |
| 2022 | 0 | — |
| 2023 | 1 | 171 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Insightec, Ltd. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRZ | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided | 2 | 0 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 2 | 2 |
| POH | Mr-Guided Focused Ultrasound System | 1 | 0 |
Review panels
Most recent Insightec, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | PLP | 2023-10-30 | 171 |
| K212150 | Exablate Prostate System | PLP | 2021-11-23 | 137 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150038 | PMA | EXABLATE | 2016-07-11 |
| P110039 | PMA | EXABLATE | 2012-10-18 |
| P040003 | PMA | EXABLATE 2000 SYSTEM | 2004-10-22 |
Recalls
openFDA lists no recalls under a recalling firm named Insightec, Ltd..
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 Insightec, Ltd. is the lead sponsor of 66 device studies on ClinicalTrials.gov (19 active or recruiting). Most recent:
- NCT05539196: A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications (Recruiting, started 2023-01-23)
- NCT05630209: Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) (Active not recruiting, started 2023-01-04)
- NCT05615623: Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG (Active not recruiting, started 2023-01-04)
- NCT05565443: MR-guided Focused Ultrasound Plus GCase (Recruiting, started 2022-11-30)
- NCT05317858: Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets (Recruiting, started 2022-08-12)
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.
- Insightec Txsonics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Insightec, Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Insightec, Ltd.” (first 2021, latest 2023), plus 3 PMA decisions, across 3 product codes in 3 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 Insightec, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Insightec, Ltd. is 154 days.
Which FDA product codes appear under Insightec, Ltd.?
The most frequent FDA product codes under this applicant name are NRZ (Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided, 2); PLP (High Intensity Ultrasound System For Prostate Tissue Ablation, 2); POH (Mr-Guided Focused Ultrasound System, 1).
Next steps
- See all 2 Insightec, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NRZ, Insightec, Ltd.'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.