510(k) Report

FDA applicant

Fairhaven Health, LLC

Bellingham, WA2 decisions2017–20190 recalls

FDA records 2 decisions for Fairhaven Health, LLC (Bellingham, WA) from 2017 to 2019: 2 510(k) clearances. Most are in product codes PEB (Lubricant, Personal, Gamete, Fertilization…) and NUC (Lubricant, Personal). Its devices cite 2 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 Fairhaven Health, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 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 — Fairhaven Health, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fairhaven Health, LLC’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?

  • PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible1decision
  • NUCLubricant, Personal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162319BabyDance Fertility LubricantFairhaven Health, LLC · 20171cites it

What has FDA decided for it lately?

  • K190150Sage 2-in-1 Personal Lubricant and MoisturizerFairhaven Health, LLC · 2019
  • K162319BabyDance Fertility LubricantFairhaven Health, LLC · 2017

All 2 as Fairhaven Health, LLC →