510(k) Report

FDA applicant

Sage In-Vitro Fertilization, Inc.

Irvine, CA2 decisions2006–20080 recalls

FDA records 2 decisions for Sage In-Vitro Fertilization, Inc. (Irvine, CA) from 2006 to 2008: 2 510(k) clearances. All are in product code MQL (Media, Reproductive). Its devices cite 5 predicates, 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, last Nov 3, 2026

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

How often FDA has decided Sage In-Vitro Fertilization, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sage In-Vitro Fertilization, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sage In-Vitro Fertilization, 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

Other applicant names beginning “Sage”

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