510(k) Report

FDA applicant

Medical Flow Systems, Ltd.

Leawood, KS1 decision2007–20072 recalls

FDA records 1 decision for Medical Flow Systems, Ltd. (Leawood, KS) in 2007: 1 510(k) clearance. All are in product code MEB (Pump, Infusion, Elastomeric). Its devices cite 1 predicate, 0 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, general hospital panel, where it files most

How often FDA has decided Medical Flow Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Flow Systems, Ltd. 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K072053Smartblock Pain PumpMedical Flow Systems, Ltd. · 20072 recalls

The one decision as Medical Flow Systems, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K072053SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.Mar 17, 2010
  • K072053SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.Jan 8, 2009