510(k) Report

FDA applicant

Sunlight Medical, Inc.

Jacksonville, FL2 decisions2008–20100 recalls

FDA records 2 decisions for Sunlight Medical, Inc. (Jacksonville, FL) from 2008 to 2010: 2 510(k) clearances. All are in product code MQH (Microtools, Assisted Reproduction (Pipettes)). 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, last Nov 3, 2026

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

How often FDA has decided Sunlight Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Sunlight Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sunlight Medical, Inc.’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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Which product codes does it file in?

  • MQHMicrotools, Assisted Reproduction (Pipettes)2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K092554Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesSunlight Medical, Inc. · 2010
  • K072600Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone Dissection and Denuding…Sunlight Medical, Inc. · 2008

All 2 as Sunlight Medical, Inc. →