FDA applicant
Stackhouse, Inc.
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
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
Class I Class II/III not classified
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.
See the 510(k) ReportOther applicant names beginning “Stackhouse”
FDA records each applicant name separately; these may or may not be the same firm.