Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Emerging Technologies Group · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
539 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961381 | KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS | The Emerging Technologies Group | 1997-09-09 | 539 | 0 |
| K961387 | MT-X | The Emerging Technologies Group | 1996-09-25 | 190 | 0 |
| K961384 | MT-2 | The Emerging Technologies Group | 1996-09-25 | 190 | 0 |
| K961383 | MT1 | The Emerging Technologies Group | 1996-09-25 | 190 | 0 |
| K961382 | MT1A | The Emerging Technologies Group | 1996-09-25 | 190 | 0 |
| K961386 | MT-2A | The Emerging Technologies Group | 1996-09-25 | 190 | 0 |
| K961385 | MT-3A | The Emerging Technologies Group | 1996-09-25 | 190 | 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