Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ultimate Wireforms, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
146 daysmedian FDA review time
244 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960799 | ORTHO-ICE | Ultimate Wireforms, Inc. | 1996-05-09 | 72 | 0 |
| K924805 | ORTHODONTIC ARCH WIRE | Ultimate Wireforms, Inc. | 1993-03-31 | 188 | 0 |
| K923837 | DIMPLED MULTI MODULUS ARCH WIRE | Ultimate Wireforms, Inc. | 1993-03-31 | 244 | 0 |
| K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | Ultimate Wireforms, Inc. | 1992-12-23 | 146 | 0 |
| K923838 | THE ULTIMATE RCS ARCH WIRE | Ultimate Wireforms, Inc. | 1992-12-04 | 127 | 0 |
| K923839 | NITINOL GENTLE TOUCH COIL SPRING | Ultimate Wireforms, Inc. | 1992-10-15 | 77 | 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