510(k) Report

FDA applicant

Lelo, Inc.

San Jose, CA3 decisions2016–20250 recalls

FDA records 3 decisions for Lelo, Inc. (San Jose, CA) from 2016 to 2025: 3 510(k) clearances. All are in product code HIS (Condom). Since 2016 its 510(k)s took a median of 123 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. 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 Lelo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12025: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Lelo, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lelo, 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?

  • HISCondom3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 123 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 102 days; 0 of its 3 were faster than that.

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?

  • K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc. · 2025
  • K162511LELO RESPECT HEX Natural Rubber Latex CondomLelo, Inc. · 2017
  • K160644Lelo Hex Natural Rubber Latex CondomLelo, Inc. · 2016

All 3 as Lelo, Inc. →