FDA applicant
Lifelines, Ltd.
FDA records 4 decisions for Lifelines, Ltd. (Crofton, MD) from 2001 to 2018: 4 510(k) clearances. Most are in product codes OLV (Standard Polysomnograph With…) and GWE (Stimulator, Photic, Evoked Response). Its devices cite 3 predicates, 1 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 Lifelines, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lifelines, Ltd.’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