510(k) Report

FDA applicant

Sandhill

Burbank, CA3 decisions1982–19860 recalls

FDA records 3 decisions for Sandhill (Burbank, CA) from 1982 to 1986: 3 510(k) clearances. Most are in product codes IXC (Illuminator, Radiographic-Film) and 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 Sandhill’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sandhill since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sandhill’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?

  • IXCIlluminator, Radiographic-Film1decision
  • FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device1decision
  • KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube1decision

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.

  • K821588Sandhill DMSSandhill · 19821cites it

What has FDA decided for it lately?

  • K863312Sandhill AmsSandhill · 1986
  • K854933Sandhill Electronic CaliperSandhill · 1986
  • K821588Sandhill DMSSandhill · 1982

All 3 as Sandhill →

Other applicant names beginning “Sandhill”

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

Sandhill Scientific, Inc. 16