510(k) Report

FDA applicant

Stackhouse, Inc.

Palm Spring, CA4 decisions1994–200014 recalls

FDA records 4 decisions for Stackhouse, Inc. (Palm Spring, CA) from 1994 to 2000: 4 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FYD (Apparatus, Exhaust, Surgical). 14 recalls are 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 Stackhouse, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stackhouse, Inc. since 2007.

Recalls per year

13in 2015

2010: 12015: 13
2007high 13 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Stackhouse, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Stackhouse”

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