510(k) Report

FDA applicant

Biofilm, Inc.

Vista, CA17 decisions1994–20220 recalls

FDA records 17 decisions for Biofilm, Inc. (Vista, CA) from 1994 to 2022: 17 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and KMJ (Lubricant, Patient). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 9 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 Biofilm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2022

2008: 12014: 22015: 12017: 22020: 22021: 12022: 4
2007high 4 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biofilm, 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

Which product codes does it file in?

  • NUCLubricant, Personal13decisions
  • KMJLubricant, Patient2decisions
  • HISCondom1decision
  • PEBLubricant, Personal, Gamete, Fertilization, And Embryo Compatible1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 143 days; 7 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 9 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.

  • K935299AstroglideBiofilm, Inc. · 199412cite it
  • K072647Glycerin & Paraben Free AstroglideBiofilm, Inc. · 20086cite it
  • K141581Astroglide NaturalBiofilm, Inc. · 20144cite it
  • K140590Astroglide Sensual StrawberryBiofilm, Inc. · 20144cite it
  • K041432Astroglide Brand Warming Liquid Personal LubricantBiofilm, Inc. · 20042cite it
  • K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 20172cite it

What has FDA decided for it lately?

  • K221036Astroglide WarmingBiofilm, Inc. · 2022
  • K220355Astroglide Ultra Gentle GelBiofilm, Inc. · 2022
  • K220653Astroglide Glycerin & Paraben FreeBiofilm, Inc. · 2022
  • K213671Astroglide Sensual Strawberry Personal LubricantBiofilm, Inc. · 2022
  • K210242Astroglide X Silicone Personal LubricantBiofilm, Inc. · 2021
  • K200239Astroglide Organix GelBiofilm, Inc. · 2020
  • K200114Astroglide Organix LiquidBiofilm, Inc. · 2020
  • K171985Astroglide O Oil Personal Lubricant & Massage OilBiofilm, Inc. · 2017

All 17 as Biofilm, Inc. →