Medispec, Ltd.: FDA clearances and approvals
Medispec, Ltd. has 4 FDA 510(k) clearances (first 1998, latest 2023), plus 2 PMA decisions, across 4 product codes in 3 review panels. Median 510(k) review time: 100 days. It is the industry lead sponsor of 4 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 736 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medispec, Ltd.'s cleared 510(k)s took a median 736 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 3 | 2 |
| FFK | Lithotriptor, Electro-Hydraulic | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| NBN | Generator, Shock-Wave, For Pain Relief | 1 | 0 |
Review panels
Most recent Medispec, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210166 | Omnispec ED1000 | ISA | 2023-01-27 | 736 |
| K063504 | ECONOLITH EM1000 | LNS | 2007-03-09 | 109 |
| K040461 | ECONOLITH E3000, MODEL 3000 (SW-6) | LNS | 2004-05-25 | 92 |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | FFK | 1998-03-12 | 80 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040026 | PMA | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE | 2005-04-01 |
| P950043 | PMA | ECONOLITH(TM) LITHOTRIPTER | 1997-04-07 |
Recalls
openFDA lists no recalls under a recalling firm named Medispec, Ltd..
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
Medispec, Ltd. is the industry lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01251185: Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure (Completed, started 2011-01)
- NCT01219218: Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris (Completed, started 2009-01)
- NCT00901056: Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction (Completed, started 2008-11)
- NCT00662727: Extracorporeal Shockwave Therapy for the Treatment of Refractory Angina Pectoris (Completed, started 2007-01)
Frequently asked questions
How many FDA 510(k) clearances does Medispec, Ltd. have?
Medispec, Ltd. has 4 FDA 510(k) clearances (first 1998, latest 2023), plus 2 PMA decisions, across 4 product codes in 3 review panels.
How long does FDA take to clear Medispec, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Medispec, Ltd.'s cleared 510(k)s is 100 days.
What devices does Medispec, Ltd. make?
Its most frequent FDA product codes are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 3); FFK (Lithotriptor, Electro-Hydraulic, 1); ISA (Massager, Therapeutic, Electric, 1).
Has Medispec, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medispec, Ltd. Related entities may recall under other names.
Next steps
- See all 4 Medispec, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Medispec, 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.