Data / Medical devices / United States / Case Medical, Inc.
Case Medical, Inc.: FDA-registered device maker in Bloomfield, NJ, United States, 17 510(k) clearances
Case Medical, Inc. is registered with the FDA (registration 2248608) in Bloomfield, NJ, United States. It lists 3 device types. The FDA files 17 510(k) clearances under its listings, the newest dated June 3, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2248608
- FEI number
- 1000526834
- Address
- 50 West St., Bloomfield, NJ, United States, 07003
- Owner or operator
- CASE MEDICAL, INC. (9020860)
- Roles
- Manufacturer
- First device listed
- November 27, 2007
- Registered through
- 2027
- Brand names listed
- 115-0010, 115-0020, 1847CNTR, 1850080, 1850081, 1850082, 1850083, 1850084 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | K252854 | SteriTite Container System with MediTray Products | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| July 31, 2024 | K240898 | SteriTite rigid reusable sterilization container with MediTray Products | KCT | Substantially Equivalent | Case Medical | accessdata.fda.gov |
| October 7, 2022 | K221492 | SteriTite Container System with MediTray Parts | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| April 29, 2022 | K212711 | SteriTite Container System with MediTray Products | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| June 13, 2018 | K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| February 10, 2017 | K161415 | SteriTite Containers System & MediTray Products | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| January 24, 2012 | K112904 | STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| July 1, 2011 | K110682 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | KCT | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| February 24, 2010 | K090068 | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| December 5, 2008 | K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| May 9, 2003 | K022978 | STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| April 7, 2003 | K023614 | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| March 21, 2003 | K030853 | STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| January 27, 2000 | K991023 | STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| February 9, 1999 | K982151 | STERITITE PROCESS INDICATOR ACCESSORIES | JOJ | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| December 18, 1997 | K974638 | STERITITE SEALED CONTAINERS MODEL SCO4Q | FRG | Substantially Equivalent | Case Medical, Inc. | accessdata.fda.gov |
| May 6, 1997 | K960738 | STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) | KCT | Substantially Equivalent | Engineered Custom Mfg., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated June 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.