Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HIS — Predicate Candidate Screening
401 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
330 days90th percentile
401clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252622 | Male Latex Condom HA | Okamoto USA, Inc. | 2026-05-04 | 258 | 0 |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom | Suretex Limited | 2025-11-18 | 99 | 0 |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 2025-07-11 | 185 | 0 |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. | 2025-03-07 | 123 | 0 |
| K243640 | Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Tr | Church & Dwight Co., Inc. | 2025-02-21 | 88 | 0 |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex Condom | Okamoto USA, Inc. | 2025-02-18 | 90 | 0 |
| K232279 | LifeStyles NRL Textured Condom | Suretex Limited | 2023-10-05 | 66 | 0 |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belg | Ttk Healthcare Limited | 2023-09-07 | 244 | 0 |
| K222611 | Male Latex Condoms | Suzhou Colour-Way New Material Co., Ltd. | 2022-11-28 | 90 | 0 |
| K220489 | Durex Patronus CloseFit, Durex Patronus Regular | Rb Health (Us), LLC | 2022-11-07 | 258 | 0 |
| K222068 | Durex Penck III Regular | Rb Health (Us), LLC | 2022-10-12 | 90 | 0 |
| K221906 | TROJAN Fire & Ice lubricated male natural rubber latex condo | Church & Dwight Co., Inc. | 2022-09-28 | 90 | 0 |
| K220576 | FAMA Male Latex Condoms | Shanghai Personage Hygiene Products Co., Ltd. | 2022-08-05 | 158 | 0 |
| K221431 | TROJAN(TM) Her Pleasure Warming male natural rubber latex co | Church & Dwight Co., Inc. | 2022-07-14 | 58 | 0 |
| K211152 | Durex Condom with Benzocaine | Rb Health (Us), LLC | 2022-05-11 | 387 | 0 |
| K213921 | Microthin Natural Rubber Latex Condom | Suretex Limited | 2022-04-28 | 134 | 0 |
| K210208 | Titan Condoms | Titan Condoms, LLC | 2022-02-17 | 387 | 0 |
| K213647 | Durex Patronus Wide | Rb Health (Us), LLC | 2022-02-17 | 90 | 0 |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth | Ttk Healthcare Limited | 2021-12-23 | 45 | 0 |
| K211450 | Playboy 3 Contour Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-30 | 143 | 0 |
| K210294 | One Touch Spiral Condom | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-23 | 233 | 0 |
| K203536 | Male Latex Condom | Global Protection Corp. | 2021-09-03 | 274 | 0 |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | Ttk Healthcare Limited | 2021-04-15 | 237 | 0 |
| K200672 | Durex Penck Standard, Durex Penck XL | Rb Health (Us), LLC | 2020-11-06 | 238 | 0 |
| K193578 | Non-spermicidal Lubricated Male Latex Condom | Global Protection Corp. | 2020-08-20 | 241 | 0 |
| K201067 | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana | Cupid Limited | 2020-08-07 | 107 | 0 |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto USA, Inc. | 2020-07-24 | 303 | 0 |
| K181844 | One Touch | Thai Nippon Rubber Industry Public Company, Ltd. | 2019-04-15 | 278 | 0 |
| K180104 | Trojan Chain Reaction Natural Rubber Latex Condom with Sensa | Church & Dwight Co., Inc. | 2018-03-14 | 57 | 0 |
| K171213 | One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. | 2018-01-12 | 262 | 0 |
| K172414 | JUD custom fit condom | Global Mailer Partners, LLC | 2017-10-12 | 63 | 0 |
| K162919 | Male Latex Condoms | Zhejiang Xiangban Latex Products Co., Ltd. | 2017-03-07 | 140 | 0 |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | Ansell Healthcare Products, LLC | 2017-01-23 | 77 | 0 |
| K162511 | LELO RESPECT HEX Natural Rubber Latex Condom | Lelo, Inc. | 2017-01-13 | 127 | 0 |
| K153016 | aoni Natural Rubber Latex Condom | Guangzhou Daming United Rubber Products , Ltd. | 2016-10-20 | 371 | 0 |
| K161915 | Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Sil | Church & Dwight Co., Inc. | 2016-09-09 | 59 | 0 |
| K161545 | Trojan XOXO Thin Male Natural Rubber Latex Condom with Silic | Church & Dwight Co., Inc. | 2016-08-26 | 84 | 0 |
| K161195 | Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and | M3 Global Enterprises, LLC | 2016-08-25 | 120 | 0 |
| K160644 | Lelo Hex Natural Rubber Latex Condom | Lelo, Inc. | 2016-06-30 | 115 | 0 |
| K150828 | O-RING Condom | O-Ring Products, LLC | 2015-12-18 | 263 | 0 |
| K150857 | Banana Gold | Hankook Latex Gongup Co., Ltd. | 2015-08-14 | 136 | 0 |
| K150072 | TheyFit Male Condom | Theyfit | 2015-04-14 | 90 | 0 |
| K132490 | SKORE AND MULTIPLE BRANDS | Ttk Protective Devices Limited (Formerly Ttk-Lig L | 2014-10-20 | 438 | 0 |
| K141059 | NATURAL RUBBER LATEX MALE CONDOMS | Karex Industries Sdn. Bhd. | 2014-08-01 | 99 | 0 |
| K141256 | OKAMOTO STUDDED CONDOM | Okamoto USA, Inc. | 2014-07-23 | 70 | 0 |
| K140379 | MEGA BIG BOY CONDOM | Okamoto USA, Inc. | 2014-07-01 | 137 | 0 |
| K131866 | SUSTAIN | Hollender Sustainable Brands, LLC | 2014-05-01 | 311 | 0 |
| K132390 | INSTINCT; PLAIN, DOTTED, ULTRA THIN | Profilatex, S.A. DE C.V. | 2014-04-22 | 264 | 0 |
| K132107 | MALE LATEX CONDOM | Nulatex Sdn. Bhd. | 2014-03-07 | 242 | 0 |
| K132597 | BLACK COLOURED CONDOM | Karex Industries Sdn. Bhd. | 2013-11-25 | 98 | 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