510(k) Report

FDA applicant

Health Care Mfg., Inc.

Springfield, MO7 decisions1995–20021 recall

FDA records 7 decisions for Health Care Mfg., Inc. (Springfield, MO) from 1995 to 2002: 7 510(k) clearances. Most are in product codes INQ (Table, Powered) and KPR (System, X-Ray, Stationary). Its devices cite 2 predicates, 0 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, physical medicine panel, where it files most

How often FDA has decided Health Care Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Care Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • INQTable, Powered4decisions
  • KPRSystem, X-Ray, Stationary2decisions
  • ITHEquipment, Traction, Powered1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K944699ATT-300Health Care Mfg., Inc. · 19951cites it

What has FDA decided for it lately?

  • K022667Hcmi X-RayHealth Care Mfg., Inc. · 2002
  • K022737Hcmi X-Ray High Requency Chiropractic RadiographicHealth Care Mfg., Inc. · 20021 recall
  • K952441LegendHealth Care Mfg., Inc. · 1995
  • K951323VH-2000Health Care Mfg., Inc. · 1995
  • K951382HLT 406Health Care Mfg., Inc. · 1995
  • K944699ATT-300Health Care Mfg., Inc. · 1995
  • K944329Back SpecialistHealth Care Mfg., Inc. · 1995

All 7 as Health Care Mfg., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K022737HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE…May 15, 2003