510(k) Report

FDA applicant

Innovative Medical Manufacturing Co.

Houston, TX3 decisions2007–20130 recalls

FDA records 3 decisions for Innovative Medical Manufacturing Co. (Houston, TX) from 2007 to 2013: 3 510(k) clearances. Most are in product codes EBW (Controller, Foot, Handpiece And Cord) and FPA (Set, Administration, Intravascular). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is 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 Innovative Medical Manufacturing Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12009: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innovative Medical Manufacturing Co. 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?

  • EBWController, Foot, Handpiece And Cord1decision
  • FPASet, Administration, Intravascular1decision
  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K131661Infusion Syringe SetInnovative Medical Manufacturing Co. · 2013
  • K090727Imm Dental Irrigation Tubing SetInnovative Medical Manufacturing Co. · 2009
  • K070801Imm Hypodermic Needle SetInnovative Medical Manufacturing Co. · 2007

All 3 as Innovative Medical Manufacturing Co. →