Case Medical, Inc.
Bloomfield, NJ, US
CASE MEDICAL, INC. appears in FDA device records in Bloomfield, NJ. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Case Medical, Inc. between 1997 and 2026. The busiest year on record is 2003, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 3 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252854 | SteriTite Container System with MediTray Products | KCT | Substantially Equivalent | |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | KCT | Substantially Equivalent | |
| K221492 | SteriTite Container System with MediTray Parts | KCT | Substantially Equivalent | |
| K212711 | SteriTite Container System with MediTray Products | KCT | Substantially Equivalent | |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | KCT | Substantially Equivalent | |
| K161415 | SteriTite Containers System & MediTray Products | FRG | Substantially Equivalent | |
| K112904 | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | |
| K110682 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | KCT | Substantially Equivalent | |
| K090068 | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS | FRG | Substantially Equivalent | |
| K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | |
| K022978 | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | |
| K023614 | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM | FRG | Substantially Equivalent | |
| K030853 | STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI | FRG | Substantially Equivalent | |
| K991023 | STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL | FRG | Substantially Equivalent | |
| K982151 | STERITITE PROCESS INDICATOR ACCESSORIES | JOJ | Substantially Equivalent | |
| K974638 | STERITITE SEALED CONTAINERS MODEL SCO4Q | FRG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2248608 | 1000526834 | CASE MEDICAL, INC. | 50 West St., Bloomfield, NJ 07003 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain