510(k) Report

FDA applicant

Estill Medical Technologies, Inc.

Dallas, TX2 decisions1999–20011 recall

FDA records 2 decisions for Estill Medical Technologies, Inc. (Dallas, TX) from 1999 to 2001: 2 510(k) clearances. All are in product code BSB (Warmer, Blood, Non-Electromagnetic Radiation). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Estill Medical Technologies, Inc. since 2007.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Estill Medical Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Estill Medical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BSBWarmer, Blood, Non-Electromagnetic Radiation2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K012031Modification to Thermal AngelEstill Medical Technologies, Inc. · 20012cite it
  • K984640Thermal AngelEstill Medical Technologies, Inc. · 19992cite it

What has FDA decided for it lately?

  • K012031Modification to Thermal AngelEstill Medical Technologies, Inc. · 20011 recall
  • K984640Thermal AngelEstill Medical Technologies, Inc. · 19991 recall

All 2 as Estill Medical Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K012031Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a…Jul 25, 2014Class II