510(k) Report

FDA applicant

Biocare Intl.

Wantagh, NY1 decision1991–19910 recalls

FDA records 1 decision for Biocare Intl. (Wantagh, NY) in 1991: 1 510(k) clearance. All are in product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Biocare Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocare Intl.’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?

  • FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device1decision

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.

  • K904646Bci-100 Fecal Incontinence SystemBiocare Intl. · 19911cites it

What has FDA decided for it lately?

  • K904646Bci-100 Fecal Incontinence SystemBiocare Intl. · 1991

The one decision as Biocare Intl. →

Other applicant names beginning “Biocare”

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

Biocare Corp. 4Biocare Asia Corporation, Ltd. 3Biocare Systems, Inc. 2Biocare Bio-Medical Equipment Co., Ltd. 1