510(k) Report

FDA applicant

Elcam Medical Acal

Mp. Merom Hagalil, IL16 decisions2003–202335 recalls

FDA records 16 decisions for Elcam Medical Acal (Mp. Merom Hagalil, IL) from 2003 to 2023: 16 510(k) clearances. Most are in product codes FMG (Stopcock, I.V. Set) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 21 predicates, 5 of them its own earlier devices. 35 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Elcam Medical Acal’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12010: 12011: 12012: 32013: 12014: 12019: 12022: 12023: 1
2007high 3 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

24in 2025

2008: 42009: 12014: 12017: 12018: 12019: 22024: 12025: 24
2007high 24 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Elcam Medical Acal by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMGStopcock, I.V. Set8decisions
  • DQOCatheter, Intravascular, Diagnostic1decision
  • DRSTransducer, Blood-Pressure, Extravascular1decision
  • DQXWire, Guide, Catheter1decision
  • FMFSyringe, Piston1decision
  • FPASet, Administration, Intravascular1decision

Also: DTL (1), KZH (1), DRG (1).

Whose devices does it build on?

Its devices cite 21 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060231Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockElcam Medical Acal · 20064cite it
  • K111016Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal · 20113cite it
  • K032393Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 20032cite it
  • K053405BacstopElcam Medical Acal · 20062cite it
  • K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP ManifoldElcam Medical Acal · 20131cites it
  • K060759Y-Click ConnectorElcam Medical Acal · 20061cites it

What has FDA decided for it lately?

  • K231900A-TAP (previously called Arthrotap)Elcam Medical Acal · 2023
  • K211204SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal · 2022
  • K190489Elcam Stopcocks and ManifoldsElcam Medical Acal · 2019
  • K141254Elcam Stopcocks and ManifoldsElcam Medical Acal · 20141 recall
  • K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP ManifoldElcam Medical Acal · 2013
  • K120253Elcam Vital Signs Wireless System (VSWS)Elcam Medical Acal · 2012
  • K120624Elcam Disposable Integrated Pressure Transducer (Dipt)Elcam Medical Acal · 2012
  • K111467Flexi-Q DV and DVR Auto-InjectorsElcam Medical Acal · 2012

All 16 as Elcam Medical Acal →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K060231Anesthesia IV Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K111016Extension Set utilized in gravity IV administration sets and pump administration sets…Oct 29, 2025Class II
  • K111016Extension Set utilized in gravity IV administration sets and pump administration sets…Oct 29, 2025Class II
  • K060231Anesthesia IV Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K111016Extension Set utilized in gravity IV administration sets and pump administration sets…Oct 29, 2025Class II
  • K032393IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II