FDA applicant
Whittlestone, Inc.
FDA records 3 decisions for Whittlestone, Inc. (Benicia, CA) from 2001 to 2007: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Whittlestone, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Whittlestone, 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