Savoy Medical Supply Co., Inc.: FDA clearances and approvals
Savoy Medical Supply Co., Inc. has 7 FDA 510(k) clearances (first 1993, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time: 321 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | 4 | 4 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Review panels
Most recent Savoy Medical Supply Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922133 | HOSPITAL KIT SV 105 | LRO | 1993-06-07 | 397 |
| K922130 | HOSPITAL KIT DK 117 | MDM | 1993-05-24 | 383 |
| K922127 | HOSPITAL KIT GP 103 | MDM | 1993-03-29 | 327 |
| K923281 | SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT | MDM | 1993-03-26 | 263 |
| K922128 | HOSPITAL KIT EP 104 | MDM | 1993-03-23 | 321 |
| K922126 | HOSPITAL KIT ENT 1125 | LRP | 1993-01-21 | 260 |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | KKX | 1993-01-04 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Savoy Medical Supply Co., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Savoy Medical Supply Co., Inc. have?
Savoy Medical Supply Co., Inc. has 7 FDA 510(k) clearances (first 1993, latest 1993), across 4 product codes in 2 review panels.
How long does FDA take to clear Savoy Medical Supply Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Savoy Medical Supply Co., Inc.'s cleared 510(k)s is 321 days.
What devices does Savoy Medical Supply Co., Inc. make?
Its most frequent FDA product codes are MDM (Instrument, Manual, Surgical, General Use, 4); KKX (Drape, Surgical, Antimicrobial, 1); LRO (General Surgery Tray, 1).
Has Savoy Medical Supply Co., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Savoy Medical Supply Co., Inc. Related entities may recall under other names.
Next steps
- See all 7 Savoy Medical Supply Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code MDM, Savoy Medical Supply Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.