Product code HIS: 510(k) clearances and predicates

Product code HIS covers FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO. FDA lists 402 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

402 clearances on file under product code HIS. Counts by year:

Year	Clearances
2022	10
2023	2
2024	0
2025	5
2026 so far	2

Recent clearances

Newest HIS clearances in the FDA index, with applicant and decision date:

• K262108, FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO, applicant Shanghai Personage Hygiene Products Co., Ltd., decided 2026-09-21. FDA record
• K252622, Male Latex Condom HA, applicant Okamoto USA, Inc., decided 2026-05-04. FDA record
• K252521, LifeStyles® HydraFeel Natural Rubber Latex Condom, applicant Suretex Limited, decided 2025-11-18. FDA record
• K250034, Natural rubber latex male condom, applicant Shaoguan Regenex Pharmaceuticals Co., Ltd., decided 2025-07-11. FDA record
• K243421, Lelo Hex Lubricated Natural Rubber Latex Condom, applicant Lelo, Inc., decided 2025-03-07. FDA record
• K243640, Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy), applicant Church & Dwight Co., Inc., decided 2025-02-21. FDA record
• K243584, 0.04 ZERO ZERO FOUR Male Latex Condom, applicant Okamoto USA, Inc., decided 2025-02-18. FDA record
• K232279, LifeStyles NRL Textured Condom, applicant Suretex Limited, decided 2023-10-05. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Male Latex Condom HA, LifeStyles® HydraFeel Natural Rubber Latex Condom. Watch new HIS clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code HIS?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HIS clearances include FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO.

How many 510(k) clearances use product code HIS?

402 at the time this page was generated, from openFDA records.

How do I find a predicate device under HIS?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new HIS clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.