510(k) Report

FDA applicant

Ivac Medical Systems

San Diego, CA2 decisions1997–19983 recalls

FDA records 2 decisions for Ivac Medical Systems (San Diego, CA) from 1997 to 1998: 2 510(k) clearances. Most are in product codes MRZ (Accessories, Pump, Infusion) and FPA (Set, Administration, Intravascular). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 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 Ivac Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivac Medical Systems since 2007.

Recalls per year

2in 2021

2016: 12021: 2
2007high 2 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ivac Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MRZAccessories, Pump, Infusion1decision
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K970485Smartsite Access PinIvac Medical Systems · 19973cite it
  • K961486Ivac Medsystem Iii, Infusion Pump W/Drug Editing Software KitIvac Medical Systems · 19981cites it

What has FDA decided for it lately?

  • K961486Ivac Medsystem Iii, Infusion Pump W/Drug Editing Software KitIvac Medical Systems · 1998
  • K970485Smartsite Access PinIvac Medical Systems · 19973 recalls

All 2 as Ivac Medical Systems →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K970485BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE…Aug 2, 2021Class II
  • K970485BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with…Aug 2, 2021Class II
  • K970485SmartSite Add-On Bag Access Device, Model No. 10013365Nov 17, 2016Class II

Other applicant names beginning “Ivac”

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

Ivac Corporation 2