Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alliance Medical, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
337 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | Alliance Medical, Inc. | 2006-04-04 | 307 | 1 |
| K050518 | REPROCESSED PHACOEMUISIFICATION TIPS | Alliance Medical, Inc. | 2005-09-23 | 206 | 0 |
| K030187 | REPROCESSED ELECTROPHYSIOLOGY CATHETER | Alliance Medical, Inc. | 2003-09-24 | 246 | 27 |
| K021654 | REPROCESSED COMPRESSION SLEEVE | Alliance Medical, Inc. | 2003-02-05 | 261 | 0 |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Alliance Medical, Inc. | 2002-06-24 | 315 | 0 |
| K012630 | REPROCESSED LINVATEC ARTHROSCOPIC BURS | Alliance Medical, Inc. | 2001-11-09 | 88 | 0 |
| K012613 | REPROCSSED LINVATEC SHAVERS | Alliance Medical, Inc. | 2001-11-07 | 86 | 1 |
| K012611 | REPROCESSED DYONICS ARTHROSCOPIC SHAVERS | Alliance Medical, Inc. | 2001-11-07 | 86 | 7 |
| K990198 | AMIB7 | Alliance Medical, Inc. | 1999-06-29 | 159 | 0 |
| K951976 | ECHO. AKHO | Alliance Medical, Inc. | 1996-07-26 | 456 | 0 |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Alliance Medical, Inc. | 1994-02-03 | 337 | 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