510(k) Report

FDA applicant

Janus Biomedical, Inc.

Austin, TX2 decisions1994–19965 recalls

FDA records 2 decisions for Janus Biomedical, Inc. (Austin, TX) from 1994 to 1996: 2 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and LPZ (Container, Frozen Donor Tissue Storage). 5 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 Janus Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Janus Biomedical, Inc. since 2007.

Recalls per year

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Janus Biomedical, Inc.’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 Bypass1decision
  • LPZContainer, Frozen Donor Tissue Storage1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K943803Jostra HL-20 Integrated Perfusion SystemJanus Biomedical, Inc. · 19962cite it
  • K915471CryobagJanus Biomedical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K943803Jostra HL-20 Integrated Perfusion SystemJanus Biomedical, Inc. · 19965 recalls
  • K915471CryobagJanus Biomedical, Inc. · 1994

All 2 as Janus Biomedical, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K943803Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL…Jun 20, 2011
  • K943803Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL…Jun 20, 2011
  • K943803Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.Sep 28, 2010
  • K943803Jostra HL-20 Heart Lung Machine - guiding pinsOct 3, 2006
  • K943803Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crankSep 1, 2006