# Case Medical, Inc.

- Location (FDA's records): Ridgefield, NJ
- FDA decisions: 16 (1997–2026): 16 510(k) clearances
- Names in FDA's records: Case Medical, Inc. (15); Case Medical (1)
- Product codes: FRG (9), KCT (6), JOJ (1)
- 510(k) review time since 2016: median 246 days, against 137 for FDA's reviews in the same codes and years (0 of 6 faster)
- Predicates its devices cite: 21 (16 its own); citations of its devices by later devices: 23 (16 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Engineered Custom Mfg., Inc.: 1 (https://510kreport.com/company/engineered-custom-mfg)
- Performance Instruments Corp.: 1 (https://510kreport.com/company/performance-instruments)
- Sterilization Cassette Systems, Inc.: 1 (https://510kreport.com/company/sterilization-cassette-systems)

## Firms that cite its devices most
- Miltex, Inc.: 3 (https://510kreport.com/company/miltex)
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Sterile Containment Technology, LLC: 1 (https://510kreport.com/company/sterile-containment-technology)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)

## Its most-cited devices
- K080558: Steritite Container System & Meditray Products (2008), cited by 4
- K022978: Steritite Container with Flashtite Valve Plate (S) & Meditray Products (2003), cited by 4
- K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl (2000), cited by 3
- K090068: Steritite Universal Container System and Meditray Products (2010), cited by 2
- K023614: Steritite Rigid Reusable Sterilization Container System (2003), cited by 2
- K212711: SteriTite Container System with MediTray Products (2022), cited by 2

## Recent decisions
- K252854: SteriTite Container System with MediTray Products (Jun 3, 2026)
- K240898: SteriTite rigid reusable sterilization container with MediTray Products (Jul 31, 2024)
- K221492: SteriTite Container System with MediTray Parts (Oct 7, 2022)
- K212711: SteriTite Container System with MediTray Products (Apr 29, 2022)
- K173259: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories (Jun 13, 2018)
- K161415: SteriTite Containers System & MediTray Products (Feb 10, 2017)
- K112904: Steritec Containers System & Meditray Products (Jan 24, 2012)
- K110682: Steritite Container System & Meditray Products (Jul 1, 2011)

Source page: https://510kreport.com/company/case-medical