FDA applicant

Biocare Systems, Inc.

Denver, CO2 decisions2004–20051 recall

FDA records 2 decisions for Biocare Systems, Inc. (Denver, CO) from 2004 to 2005: 2 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 4 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, physical medicine panel, where it files most

How often FDA has decided Biocare Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biocare Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocare Systems, 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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Other applicant names beginning “Biocare”

FDA records each applicant name separately; these may or may not be the same firm.

Biocare Corp. 4 Biocare Asia Corporation, Ltd. 3 Biocare Intl. 1 Biocare Bio-Medical Equipment Co., Ltd. 1

Biocare Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Biocare”