510(k) Report

FDA applicant

Algos, LC

Ann Arbor, MI1 decision2004–200446 recalls

FDA records 1 decision for Algos, LC (Ann Arbor, MI) in 2004: 1 510(k) clearance. All are in product code MEB (Pump, Infusion, Elastomeric). 46 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 Algos, LC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Algos, LC since 2007.

Recalls per year

46in 2009

2009: 46
2007high 46 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Algos, LC 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?

  • MEBPump, Infusion, Elastomeric1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K041585Autofuser Ambulatory Infusion PumpAlgos, LC · 20041cites it

What has FDA decided for it lately?

  • K041585Autofuser Ambulatory Infusion PumpAlgos, LC · 200446 recalls

The one decision as Algos, LC →

What has been recalled?

46 recalls linked to its devices; the latest:

  • K041585Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in.…May 14, 2009
  • K041585Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60…May 14, 2009
  • K041585Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr,standard catheter…May 14, 2009
  • K041585Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF…May 14, 2009
  • K041585Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter…May 14, 2009
  • K041585Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60…May 14, 2009