510(k) Report

FDA applicant

Ndm Acquisition Corp.

Dayton, OH4 decisions1991–19940 recalls

FDA records 4 decisions for Ndm Acquisition Corp. (Dayton, OH) from 1991 to 1994: 4 510(k) clearances. Most are in product codes NAE (Dressing, Wound, Hydrogel Without Drug And/Or…) and DRX (Electrode, Electrocardiograph). 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 and plastic surgery panel, where it files most

How often FDA has decided Ndm Acquisition Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ndm Acquisition Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ndm Acquisition Corp. 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?

  • NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic2decisions
  • DRXElectrode, Electrocardiograph1decision
  • JOWSleeve, Limb, Compressible1decision

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.

  • K914207Clearsite (R) Sterile Wound Care DressingNdm Acquisition Corp. · 19911cites it

What has FDA decided for it lately?

  • K943287Act-One Advanced Compression Technology Foot PumpNdm Acquisition Corp. · 1994
  • K934601NDM Hydrogauze Wound DressingNdm Acquisition Corp. · 1994
  • K931457NDM Silvon Ecg ElectrodesNdm Acquisition Corp. · 1993
  • K914207Clearsite (R) Sterile Wound Care DressingNdm Acquisition Corp. · 1991

All 4 as Ndm Acquisition Corp. →