SepaSperm Washing Solution, SepaSperm Solution
510(k) K190199
SepaSperm Washing Solution, SepaSperm Solution is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Kitazato Corporation, cleared under FDA 510(k) K190199 on 26 Sep 2019, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190199 | Date26 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K190199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190199
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sepa Sperm 40% | 92035 / Sepa Sperm 40% | 04573316381263 | — | On the market |
| Sepa Sperm 40% | 92041 / Sepa Sperm 40% | 04573316381294 | — | On the market |
| Sepa Sperm 60% | 92034 / Sepa Sperm 60% | 04573316381256 | — | On the market |
| Sepa Sperm 60% | 92040 / Sepa Sperm 60% | 04573316381287 | — | On the market |
| Sepa Sperm 80% | 92033 / Sepa Sperm 80% | 04573316381249 | — | On the market |
| Sepa Sperm 80% | 92039 / Sepa Sperm 80% | 04573316381270 | — | On the market |
| Sepa Sperm Solution | 92148 / Sepa Sperm Solution | 04573316381300 | — | On the market |
| Sepa Sperm Wash Solution | 92149 / Sepa Sperm Wash Solution | 04573316381317 | — | On the market |
Similar devices
Other devices filed under FDA product code MQL (Media, Reproductive).
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- Global Fertilization, Embryo Culture and Transfer Media by <Genx> Intl., Inc.
- Oil for Embryo Culture 9305-500ML by IRVINE SCIENTIFIC, LLC
- G-2 V5 by Vitrolife Sweden AB
- Enhance Sperm Freeze by Conception Technology, Inc.
- AllGrad 45 and 90 Cell Separation Media by <Genx> Intl., Inc.
- Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit by Willian A. Cook Australia Pty, Ltd.
- Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) by Shandong Wego Ruisheng Medical Device Co., Ltd.
- PVP-Polyvinylpyrrolidone Reagent, Model Cat#2210 by INVITROCARE INC