510(k) Report

FDA applicant

Rand S.R.L.

Minneapolis, MN4 decisions2006–20162 recalls

FDA records 4 decisions for Rand S.R.L. (Minneapolis, MN) from 2006 to 2016: 4 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and LGZ (Warmer, Thermal, Infusion Fluid). Its devices cite 8 predicates, 2 of them its own earlier devices. 2 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, cardiovascular panel, where it files most

How often FDA has decided Rand S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 12012: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Rand S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2decisions
  • LGZWarmer, Thermal, Infusion Fluid2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 20062cite it
  • K120026Performer HT/ Hang&GO HT BasicRand S.R.L. · 20121cites it
  • K070213Performer CBP SystemRand S.R.L. · 20071cites it

What has FDA decided for it lately?

  • K161613Hang&Go PACRand S.R.L. · 20161 recall
  • K120026Performer HT/ Hang&GO HT BasicRand S.R.L. · 2012
  • K070213Performer CBP SystemRand S.R.L. · 20071 recall
  • K052555Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 20061 recall

All 4 as Rand S.R.L. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K161613Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120Apr 30, 2021Class II
  • K052555Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB…Jun 4, 2007

Other applicant names beginning “Rand”

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

Rand Scientific Corp. 10