FDA applicant
Mayborn Baby and Child / Jackel International, Ltd.
FDA records 1 decision for Mayborn Baby and Child / Jackel International, Ltd. (Cramlington, Northumberland, GB) in 2011: 1 510(k) clearance. All are in product code HGX (Pump, Breast, Powered). Its devices cite 1 predicate, 0 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
How often FDA has decided Mayborn Baby and Child / Jackel International, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Mayborn Baby and Child / Jackel…’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 “Mayborn”
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