Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nobles Medical Technologies Ii, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017-04-06 | 198 | 0 |
| K113494 | NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA | Nobles Medical Technologies Ii, Inc. | 2012-04-19 | 146 | 0 |
| K113763 | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE | Nobles Medical Technologies Ii, Inc. | 2012-03-16 | 86 | 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