FDA applicant

Sage Biopharma

Irvine, CA6 decisions1999–20002 recalls

FDA records 6 decisions for Sage Biopharma (Irvine, CA) from 1999 to 2000: 6 510(k) clearances. All are in product code MQL (Media, Reproductive). 2 recalls are 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 Biopharma’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sage Biopharma since 2007.

Recalls per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sage Biopharma’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Sage”

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

Sage Products, Inc. 31 Sage Pharmaceuticals, Inc. 2 Sage In-Vitro Fertilization, Inc. 2 Sage Laboratories, Inc. 1 Sage Electronics Products, Inc. 1

Sage Biopharma

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sage”