510(k) Report

FDA applicant

Church & Dwight Co., Inc.

Princeton, NJ29 decisions2006–20253 recalls

FDA records 29 decisions for Church & Dwight Co., Inc. (Princeton, NJ) from 2006 to 2025: 29 510(k) clearances. Most are in product codes HIS (Condom) and NUC (Lubricant, Personal). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 13 of them its own earlier devices. 3 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 Church & Dwight Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 42009: 12011: 12012: 42013: 42014: 12015: 12016: 32017: 12018: 22020: 12021: 12022: 22024: 12025: 1
2007high 4 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2023

2022: 12023: 2
2007high 2 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Church & Dwight Co., 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?

  • HISCondom12decisions
  • NUCLubricant, Personal8decisions
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter4decisions
  • MOLCondom, Synthetic4decisions
  • 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 115 days; 6 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 30 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 34 times; 13 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.

  • K123436First Response Early Result Pregnancy TestChurch & Dwight Co., Inc. · 20136cite it
  • K131887Trojan Jaguar Male Natural Rubber Latex Condom with Warming and Tingling LubricantChurch & Dwight Co., Inc. · 20133cite it
  • K073016Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm Sensations LubricantChurch & Dwight Co., Inc. · 20073cite it
  • K071313Trojan-Enz BrandChurch & Dwight Co., Inc. · 20073cite it
  • K123567First Response Gold Digital Pregnancy TestChurch & Dwight Co., Inc. · 20132cite it
  • K100767Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. · 20112cite it

What has FDA decided for it lately?

  • K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc. · 2025
  • K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc. · 2024
  • K221906TROJAN Fire & Ice lubricated male natural rubber latex condomChurch & Dwight Co., Inc. · 2022
  • K221431TROJAN (TM) Her Pleasure Warming male natural rubber latex condom with warming lubricantChurch & Dwight Co., Inc. · 2022
  • K203818Replens Long-Lasting Vaginal MoisturizerChurch & Dwight Co., Inc. · 2021
  • K193450Pre-Seed™ Fertility LubricantChurch & Dwight Co., Inc. · 2020
  • K180764TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)Church & Dwight Co., Inc. · 2018
  • K180104Trojan Chain Reaction Natural Rubber Latex Condom with Sensate LubricantChurch & Dwight Co., Inc. · 2018

All 29 as Church & Dwight Co., Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K123436First Response 2 CT, Sku 902343Oct 4, 2023Class II
  • K083716Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of…Jan 25, 2023Class II
  • K123436First Response 2 CT, Sku 902343Jun 23, 2022Class II

Other applicant names beginning “Church”

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

Church & Dwight Virginia Co., Inc. 1