Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Savoy Medical Supply Co., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
321 daysmedian FDA review time
397 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922133 | HOSPITAL KIT SV 105 | Savoy Medical Supply Co., Inc. | 1993-06-07 | 397 | 0 |
| K922130 | HOSPITAL KIT DK 117 | Savoy Medical Supply Co., Inc. | 1993-05-24 | 383 | 0 |
| K922127 | HOSPITAL KIT GP 103 | Savoy Medical Supply Co., Inc. | 1993-03-29 | 327 | 0 |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | 1993-03-26 | 263 | 0 |
| K922128 | HOSPITAL KIT EP 104 | Savoy Medical Supply Co., Inc. | 1993-03-23 | 321 | 0 |
| K922126 | HOSPITAL KIT ENT 1125 | Savoy Medical Supply Co., Inc. | 1993-01-21 | 260 | 0 |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | Savoy Medical Supply Co., Inc. | 1993-01-04 | 182 | 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