510(k) Report

FDA applicant

Kci New Technologies, Inc.

San Antonio, TX3 decisions1997–19990 recalls

FDA records 3 decisions for Kci New Technologies, Inc. (San Antonio, TX) from 1997 to 1999: 3 510(k) clearances. Most are in product codes IZH (System, X-Ray, Mammographic) and JOW (Sleeve, Limb, Compressible). Its devices cite 1 predicate, 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, radiology panel, where it files most

How often FDA has decided Kci New Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kci New Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kci New Technologies, Inc. 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?

  • IZHSystem, X-Ray, Mammographic2decisions
  • JOWSleeve, Limb, Compressible1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 8 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.

  • K981311Cowboy XVKci New Technologies, Inc. · 19998cite it

What has FDA decided for it lately?

  • K981311Cowboy XVKci New Technologies, Inc. · 1999
  • K980235Remote Hand Control to the Inflatable Positioning Cushion (a.K.a. Imageair)Kci New Technologies, Inc. · 1998
  • K973915Inflatable Positioning CushionsKci New Technologies, Inc. · 1997

All 3 as Kci New Technologies, Inc. →