510(k) Report

FDA applicant

Safe Obstetric Systems, Ltd.

Shenfield, GB1 decision2017–20170 recalls

FDA records 1 decision for Safe Obstetric Systems, Ltd. (Shenfield, GB) in 2017: 1 De Novo grant. All are in product code PWB (Fetal Head Elevator). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Safe Obstetric Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Safe Obstetric Systems, Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Safe”

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