Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Electronics, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
258 daysmedian FDA review time
467 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951232 | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5M | American Medical Electronics, Inc. | 1995-08-25 | 158 | 0 |
| K952348 | OGDEN ANCHOR | American Medical Electronics, Inc. | 1995-08-21 | 94 | 0 |
| K950875 | OGDEN ANCHOR | American Medical Electronics, Inc. | 1995-07-11 | 133 | 0 |
| K951493 | OGDEN ANCHOR | American Medical Electronics, Inc. | 1995-07-03 | 94 | 0 |
| K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS | American Medical Electronics, Inc. | 1995-07-03 | 95 | 0 |
| K941029 | OGDEN ANCHOR-SMALL (TENTATIVE) | American Medical Electronics, Inc. | 1995-02-09 | 339 | 0 |
| K931381 | AME UNIVERSAL FIXATION SYSTEM | American Medical Electronics, Inc. | 1995-02-01 | 685 | 0 |
| K935065 | OGDEN ANCHOR ADDITIONAL APPLICATIONS | American Medical Electronics, Inc. | 1995-01-30 | 467 | 0 |
| K942300 | SILKON TITANIUM CABLE SYSTEM | American Medical Electronics, Inc. | 1995-01-09 | 242 | 0 |
| K935167 | OGDEN ANCHOR (MODIFICATION) | American Medical Electronics, Inc. | 1994-07-12 | 258 | 0 |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | American Medical Electronics, Inc. | 1994-05-03 | 334 | 0 |
| K930107 | AME UNIVERSAL BONE SCREW | American Medical Electronics, Inc. | 1994-02-22 | 407 | 0 |
| K930531 | AME(R) RIGID FIXATION SYSTEM | American Medical Electronics, Inc. | 1994-02-01 | 364 | 0 |
| K884798 | AME PINSITE SHIELD(TM) | American Medical Electronics, Inc. | 1989-02-10 | 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