# Elcam Medical Acal

- Location (FDA's records): Mp. Merom Hagalil, IL
- FDA decisions: 16 (2003–2023): 16 510(k) clearances
- Product codes: FMG (8), DQO (1), DRS (1), DQX (1), FMF (1), FPA (1), DTL (1), KZH (1), DRG (1)
- Predicates its devices cite: 21 (5 its own); citations of its devices by later devices: 14 (5 its own)
- Recalls linked to its devices: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Device Consultants, Inc.: 4 (https://510kreport.com/company/medical-device-consultants)
- Hospira, Inc.: 2 (https://510kreport.com/company/hospira)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- The Kipp Group: 1 (https://510kreport.com/company/kipp-group)
- Medex, Inc.: 1 (https://510kreport.com/company/medex)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Boston Scientific Corporation Northwest Technology: 1 (https://510kreport.com/company/boston-scientific-northwest-technology)
- Scientific Device Manufacturer, LLC: 1 (https://510kreport.com/company/scientific-device-manufacturer)

## Firms that cite its devices most
- Acacia, Inc.: 1 (https://510kreport.com/company/acacia)
- Rex Medical: 1 (https://510kreport.com/company/rex-medical)
- Device Partners International: 1 (https://510kreport.com/company/device-partners-international)
- M/S Romsons International: 1 (https://510kreport.com/company/m-s-romsons-international)
- Yomura Technologies, Inc.: 1 (https://510kreport.com/company/yomura-technologies)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Dynarex Corp.: 1 (https://510kreport.com/company/dynarex)
- Medex, Inc.: 1 (https://510kreport.com/company/medex)

## Its most-cited devices
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock (2006), cited by 4
- K111016: Safeport Manifold (TM) (or Stopcock) (2011), cited by 3
- K032393: Induction and Sampling Manifold (or Stopcock) (2003), cited by 2
- K053405: Bacstop (2006), cited by 2
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold (2013), cited by 1
- K060759: Y-Click Connector (2006), cited by 1

## Recent decisions
- K231900: A-TAP (previously called Arthrotap) (Jul 25, 2023)
- K211204: SafePort (TM) Manifold (or Stopcock) (Sep 15, 2022)
- K190489: Elcam Stopcocks and Manifolds (Apr 23, 2019)
- K141254: Elcam Stopcocks and Manifolds (Jul 30, 2014)
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold (May 23, 2013)
- K120253: Elcam Vital Signs Wireless System (VSWS) (Jul 16, 2012)
- K120624: Elcam Disposable Integrated Pressure Transducer (Dipt) (Jun 8, 2012)
- K111467: Flexi-Q DV and DVR Auto-Injectors (Feb 9, 2012)

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