Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smart Medical Systems , Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
209 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | 2022-04-11 | 82 | 0 |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | 2020-10-26 | 60 | 0 |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | 2020-04-15 | 209 | 0 |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | Smart Medical Systems , Ltd. | 2012-02-06 | 199 | 0 |
| K111760 | NAVIAID(TM) BGC DEVICE | Smart Medical Systems , Ltd. | 2011-08-09 | 48 | 0 |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B | Smart Medical Systems , Ltd. | 2011-06-17 | 136 | 0 |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | Smart Medical Systems , Ltd. | 2010-12-30 | 111 | 0 |
| K101191 | NAVIAID ICVI DEVICE | Smart Medical Systems , Ltd. | 2010-07-27 | 90 | 0 |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | Smart Medical Systems , Ltd. | 2006-08-15 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda