Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Superdimension, Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
61 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102604 | I-LOGIC INREACH SYSTEM | Superdimension, Ltd. | 2010-10-07 | 27 | 0 |
| K092365 | INREACH SYSTEM, MODEL AAS00161-02 | Superdimension, Ltd. | 2009-09-04 | 30 | 0 |
| K082386 | INREACH PLANNING LAPTOP | Superdimension, Ltd. | 2008-09-16 | 28 | 0 |
| K081379 | MODIFICATION TO INREACH SYSTEM | Superdimension, Ltd. | 2008-06-11 | 26 | 0 |
| K080271 | INREACH SYSTEM | Superdimension, Ltd. | 2008-03-31 | 59 | 0 |
| K071473 | MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 | Superdimension, Ltd. | 2007-07-12 | 44 | 0 |
| K062315 | SUPERDIMENSION/BRONCHUS PREMIUM 2 | Superdimension, Ltd. | 2006-09-08 | 30 | 1 |
| K052852 | SUPERDIMENSION/BRONCHUS PREMIUM | Superdimension, Ltd. | 2005-11-14 | 34 | 1 |
| K052260 | SUPERDIMENSION/BRONCHUS 4.1 | Superdimension, Ltd. | 2005-09-08 | 20 | 2 |
| K042438 | SUPERDIMENSION/BRONCHUS | Superdimension, Ltd. | 2004-11-08 | 61 | 1 |
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