Case Medical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Case Medical, Inc.” (first 1997, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 240 days. Since 2017 the median was 246 days, against 147 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 112 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 263 |
| 2018 | 1 | 246 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 192 |
| 2023 | 0 | — |
| 2024 | 1 | 121 |
| 2025 | 0 | — |
| 2026 | 1 | 268 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Case Medical, Inc. took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRG | Wrap, Sterilization | 9 | 9 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 6 | 6 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 1 | 1 |
Review panels
- General Hospital (16)
Most recent Case Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252854 | SteriTite Container System with MediTray Products | KCT | 2026-06-03 | 268 |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | KCT | 2024-07-31 | 121 |
| K221492 | SteriTite Container System with MediTray Parts | KCT | 2022-10-07 | 137 |
| K212711 | SteriTite Container System with MediTray Products | KCT | 2022-04-29 | 246 |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | KCT | 2018-06-13 | 246 |
| K161415 | SteriTite Containers System & MediTray Products | FRG | 2017-02-10 | 263 |
| K112904 | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS | FRG | 2012-01-24 | 112 |
| K110682 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | KCT | 2011-07-01 | 113 |
| K090068 | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS | FRG | 2010-02-24 | 411 |
| K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | FRG | 2008-12-05 | 281 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Case Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Case Medical, Inc. (15)
- Case Medical (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Case Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Case Medical, Inc.?
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Case Medical, Inc.” (first 1997, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Case Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Case Medical, Inc. is 240 days. Since 2017: 246 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Case Medical, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 9); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 6); JOJ (Indicator, Physical/Chemical Sterilization Process, 1).
Next steps
- See all 16 Case Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Case Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.