Smart Medical Systems , Ltd.: FDA clearances and approvals
Smart Medical Systems , Ltd. has 9 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time: 111 days. Since 2017 its median was 82 days, against 129 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 199 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 134 |
| 2021 | 0 | — |
| 2022 | 1 | 82 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Smart Medical Systems , Ltd.'s cleared 510(k)s took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | 5 | 5 |
| ODC | Endoscope Channel Accessory | 3 | 3 |
| FDA | Enteroscope And Accessories | 1 | 1 |
Review panels
Most recent Smart Medical Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220158 | G-EYE System | FDF | 2022-04-11 | 82 |
| K202469 | G-EYE System | FDF | 2020-10-26 | 60 |
| K192588 | G-EYE System | FDF | 2020-04-15 | 209 |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | ODC | 2012-02-06 | 199 |
| K111760 | NAVIAID(TM) BGC DEVICE | ODC | 2011-08-09 | 48 |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE | ODC | 2011-06-17 | 136 |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | FDF | 2010-12-30 | 111 |
| K101191 | NAVIAID ICVI DEVICE | FDF | 2010-07-27 | 90 |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | FDA | 2006-08-15 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Smart Medical Systems , 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
Smart Medical Systems , Ltd. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01917513: Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy (Completed, started 2014-05)
- NCT01749722: Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy (Completed, started 2012-11)
- NCT00398203: Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment (Completed, started 2008-02)
Frequently asked questions
How many FDA 510(k) clearances does Smart Medical Systems , Ltd. have?
Smart Medical Systems , Ltd. has 9 FDA 510(k) clearances (first 2006, latest 2022), across 3 product codes in 1 review panel.
How long does FDA take to clear Smart Medical Systems , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Smart Medical Systems , Ltd.'s cleared 510(k)s is 111 days. Since 2017: 82 days, versus 129 days for all cleared 510(k)s in the same product codes.
What devices does Smart Medical Systems , Ltd. make?
Its most frequent FDA product codes are FDF (Colonoscope And Accessories, Flexible/Rigid, 5); ODC (Endoscope Channel Accessory, 3); FDA (Enteroscope And Accessories, 1).
Has Smart Medical Systems , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Smart Medical Systems , Ltd. Related entities may recall under other names.
Next steps
- See all 9 Smart Medical Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FDF, Smart Medical Systems , 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.