FDA applicant

Indigo Medical, Inc.

Palo Alto, CA6 decisions1996–19990 recalls

FDA records 6 decisions for Indigo Medical, Inc. (Palo Alto, CA) from 1996 to 1999: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and KXK (Source, Brachytherapy, Radionuclide). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Indigo Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Indigo Medical, 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 “Indigo”

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

Indigo Orb, Inc. 1 Indigo Technologies 1

Indigo Medical, 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?

Other applicant names beginning “Indigo”