Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Volume Interactions Pte, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
51 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071054 | RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 | Volume Interactions Pte, Ltd. | 2007-05-22 | 36 | 0 |
| K063730 | DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODE | Volume Interactions Pte, Ltd. | 2007-01-31 | 44 | 0 |
| K053162 | DEXTROSCOPE & DEXTROBEAM | Volume Interactions Pte, Ltd. | 2005-12-09 | 25 | 0 |
| K032924 | RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROB | Volume Interactions Pte, Ltd. | 2003-10-10 | 18 | 0 |
| K022938 | VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 | Volume Interactions Pte, Ltd. | 2002-10-25 | 51 | 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