FDA applicant

Gibeck, Inc.

Indianapolis, IN15 decisions1990–19976 recalls

FDA records 15 decisions for Gibeck, Inc. (Indianapolis, IN) from 1990 to 1997: 15 510(k) clearances. Most are in product codes BYD (Condenser, Heat And Moisture (Artificial Nose)) and CAH (Filter, Bacterial, Breathing-Circuit). 6 recalls are linked to its devices, 6 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Gibeck, Inc. since 2007.

Recalls per year

6in 2022

2007high 6 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Gibeck”

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

Gibeck Respiration 6

Gibeck, Inc.

Which product codes does it file in?

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 “Gibeck”