Prophylactic (Condom)
FDA 510(k) K854622 · Medelec Intl. Corp.
510(k) numberK854622
Submission
- Device name
- Prophylactic (Condom)
- Applicant
- Medelec Intl. Corp.
Miami Beach, FL, US - Received
- November 18, 1985
- Decision date
- April 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIS – Condom
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252622 | Male Latex Condom HAHIS · Abbreviated | Okamoto USA, Inc. | 05/04/2026SE |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated | Suretex Limited | 11/18/2025SE |
| K250034 | Natural rubber latex male condomHIS · Traditional | Shaoguan Regenex Pharmaceuticals Co., Ltd. | 07/11/2025SE |
| K243421 | Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional | Lelo, Inc. | 03/07/2025SE |
| K243640 | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional | Church & Dwight Co., Inc. | 02/21/2025SE |
| K243584 | 0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated | Okamoto USA, Inc. | 02/18/2025SE |
| K232279 | LifeStyles NRL Textured CondomHIS · Abbreviated | Suretex Limited | 10/05/2023SE |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional | Ttk Healthcare Limited | 09/07/2023SE |
| K222611 | Male Latex CondomsHIS · Traditional | Suzhou Colour-Way New Material Co., Ltd. | 11/28/2022SE |
| K220489 | Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional | Rb Health (Us), LLC | 11/07/2022SE |
More from Rb Health (Us), LLC
| 510(k) | Device | Decision |
|---|---|---|
| K961013 | Disposable Needle ElectrodeIKT · Traditional | 12/20/1996SE |
| K935017 | TD50 ElectromyographJXE · Traditional | 07/28/1994SE |
| K922548 | Medelec 2110 and 2114 EEGGWQ · Traditional | 11/03/1992SE |
| K920127 | Electroencephalograph Recording SystemGWQ · Traditional | 06/10/1992SE |
| K912775 | Sapphire 4ME Emg/Ep SystemGWF · Traditional | 11/08/1991SE |
| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
| K863491 | Blood Specimen Collection DevicesJKA · Traditional | 10/24/1986SE |
| K854562 | Connector, Blood Tubing, Infusion T. Intravenous IBRZ · Traditional | 01/09/1986SE |
| K854860 | Blades, Scalpel Carbon SteetGES · Traditional | 12/24/1985SE |
| K854859 | Blades, Scalpel Stainless SteelGES · Traditional | 12/24/1985SE |
Questions and answers
When was Prophylactic (Condom) cleared by the FDA?
Prophylactic (Condom) (K854622) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 144 days after the submission was received.
What is the product code of K854622?
The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.