510(k) Report

FDA applicant

Imed Corp.

San Diego, CA43 decisions1977–199630 recalls

FDA records 43 decisions for Imed Corp. (San Diego, CA) from 1977 to 1996: 43 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). 30 recalls are linked to its devices, 5 Class I.

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 Imed Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Imed Corp. since 2007.

Recalls per year

3in 2021

2007: 12008: 42009: 22012: 2, 2 Class I2013: 32014: 2, 1 Class I2015: 12016: 2, 1 Class I2017: 42018: 12019: 3, 1 Class I2021: 3
2007high 4 (2008) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Imed Corp. 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?

  • FRNPump, Infusion22decisions
  • FPASet, Administration, Intravascular12decisions
  • FLNMonitor, Electric For Gravity Flow Infusion Systems4decisions
  • FPBFilter, Infusion Line2decisions
  • MEBPump, Infusion, Elastomeric1decision
  • LDRController, Infusion, Intravascular, Electronic1decision

Also: BWB (1).

Who builds on its devices?

Later devices cite its devices 17 times; 0 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.

  • K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 19955cite it
  • K944320Vented/Non-Vented Gemini Administration SetImed Corp. · 19955cite it
  • K945070Versasae Plastic Cannula- 11 GaugeImed Corp. · 19953cite it
  • K931173Primary Admin Set W/Univ SP-Man Below/Abv Pump CHImed Corp. · 19942cite it
  • K953896The Imed Ambulatory Infusion Pump, Administration SetsImed Corp. · 19961cites it
  • K870991Imed (R) Model 960A Volumetric Infusion PumpImed Corp. · 19871cites it

What has FDA decided for it lately?

  • K960512Gemini PC-ItxImed Corp. · 1996
  • K953896The Imed Ambulatory Infusion Pump, Administration SetsImed Corp. · 19961 recall
  • K950153Vented/Nonvented Gemini Administration Set with Check Valve and Two Safsite (TM) ValvesImed Corp. · 1995
  • K951922Administration Sets with Ball FloatImed Corp. · 19951 recall
  • K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 19954 Class I recalls
  • K944320Vented/Non-Vented Gemini Administration SetImed Corp. · 19957 recalls
  • K945070Versasae Plastic Cannula- 11 GaugeImed Corp. · 19951 recall
  • K931173Primary Admin Set W/Univ SP-Man Below/Abv Pump CHImed Corp. · 19943 recalls

All 43 as Imed Corp. →

What has been recalled?

30 recalls linked to its devices; the latest:

  • K944320BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port…Aug 2, 2021Class II
  • K951922BD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP CHAMBER, REF: 10012564Aug 2, 2021Class II
  • K931173BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF…Aug 2, 2021Class II
  • K894842Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414…May 6, 2019Class I
  • K931173Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07Mar 5, 2019Class II
  • K931173Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07Mar 5, 2019Class II

Other applicant names beginning “Imed”

FDA records each applicant name separately; these may or may not be the same firm.

Imed Technology, Inc. 2Imed Ireland, Ltd. 1Imed Systems & Consulting, LLC 1