FDA applicant

Sierra Scientific Instruments, Inc.

San Diego, CA2 decisions2003–20091 recall

FDA records 2 decisions for Sierra Scientific Instruments, Inc. (San Diego, CA) from 2003 to 2009: 2 510(k) clearances. All are in product code FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 5 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sierra Scientific Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sierra Scientific Instruments, 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

Other applicant names beginning “Sierra”

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

Sierra Laboratories, Inc. 12 Sierra Medical Devices 2 Sierra Corp. 1 Sierra Diagnostic, LLC 1 Sierra Biosearch, Inc. 1 Sierra Diagnostics 1 Sierra Surgical, Inc. 1 Sierra Battery, Inc. 1

Sierra Scientific Instruments, 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 “Sierra”