Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Church & Dwight Co., Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
128 daysmedian FDA review time
294 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Tr | Church & Dwight Co., Inc. | 2025-02-21 | 88 | 0 |
| K240379 | TROJAN SIS Synthetic Latex Condom with Silicone Lubricant | Church & Dwight Co., Inc. | 2024-10-08 | 244 | 0 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condo | Church & Dwight Co., Inc. | 2022-09-28 | 90 | 0 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex co | Church & Dwight Co., Inc. | 2022-07-14 | 58 | 0 |
| K203818 | Replens Long-Lasting Vaginal Moisturizer | Church & Dwight Co., Inc. | 2021-06-11 | 164 | 0 |
| K193450 | Pre-Seed™ Fertility Lubricant | Church & Dwight Co., Inc. | 2020-07-23 | 223 | 0 |
| K180764 | TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Person | Church & Dwight Co., Inc. | 2018-08-01 | 131 | 0 |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensa | Church & Dwight Co., Inc. | 2018-03-14 | 57 | 0 |
| K171639 | Trojan Supra Lubricated Polyurethane Male Condom | Church & Dwight Co., Inc. | 2017-08-01 | 60 | 0 |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Sil | Church & Dwight Co., Inc. | 2016-09-09 | 59 | 0 |
| K161544 | Trojan Chain Reaction Personal Lubricant | Church & Dwight Co., Inc. | 2016-08-31 | 89 | 0 |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silic | Church & Dwight Co., Inc. | 2016-08-26 | 84 | 0 |
| K150886 | Trojan Riviera Personal Lubricant | Church & Dwight Co., Inc. | 2015-07-20 | 109 | 0 |
| K141034 | AZUL PERSONAL LUBRICANT | Church & Dwight Co., Inc. | 2014-07-21 | 90 | 0 |
| K131887 | TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING | Church & Dwight Co., Inc. | 2013-10-24 | 121 | 0 |
| K123567 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-09-10 | 294 | 0 |
| K123436 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST | Church & Dwight Co., Inc. | 2013-08-26 | 292 | 2 |
| K123427 | NIRVANA D PERSONAL LUBRICANT (TBD) | Church & Dwight Co., Inc. | 2013-06-28 | 233 | 0 |
| K120706 | NIRVANA A PERSONAL LUBRICANT | Church & Dwight Co., Inc. | 2012-10-04 | 210 | 0 |
| K120751 | NIRVANA B PERSONAL LUBRICANT | Church & Dwight Co., Inc. | 2012-10-03 | 205 | 0 |
| K120286 | TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRI | Church & Dwight Co., Inc. | 2012-06-19 | 140 | 0 |
| K120287 | TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT | Church & Dwight Co., Inc. | 2012-05-16 | 106 | 0 |
| K100767 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2011-04-05 | 383 | 0 |
| K083716 | FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) | Church & Dwight Co., Inc. | 2009-06-08 | 175 | 1 |
| K073016 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH U | Church & Dwight Co., Inc. | 2007-11-09 | 15 | 0 |
| K071313 | TROJAN-ENZ BRAND | Church & Dwight Co., Inc. | 2007-10-26 | 169 | 0 |
| K071272 | TROJAN THINTENSITY BRAND MALE LATEX CONDOM | Church & Dwight Co., Inc. | 2007-09-12 | 128 | 0 |
| K070054 | FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST | Church & Dwight Co., Inc. | 2007-05-04 | 120 | 0 |
| K050828 | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM | Church & Dwight Co., Inc. | 2006-02-28 | 333 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda