Submission Details
| 510(k) Number | K181461 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 04, 2018 |
| Decision Date | January 04, 2019 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
Rapid-i? Kit
Jan 2019
Decision
214d
Days
Class 2
Risk
About This 510(k) Submission
K181461 is an FDA 510(k) clearance for the Rapid-i? Kit, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Vitrolife Sweden AB (V?stra Fr?lunda, SE). The FDA issued a Cleared decision on January 4, 2019, 214 days after receiving the submission on June 4, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
Device Classification
| Product Code | MQK — Labware, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6160 |
Manufacturer
Similar Devices — MQK Labware, Assisted Reproduction
All 49
K241626 · Ipreg Incorporation
· Feb 2025
K241454 · Guangzhou Hehong Biotech Co., Ltd.
· Feb 2025
K241348 · Motilitycount Aps
· Jan 2025
K241341 · Fujifilm Irvine Scientific
· Sep 2024
K240002 · Gimbo Medical Technology Shenzhen Co., Ltd.
· Jun 2024
K232980 · Cytoswim, Ltd.
· Mar 2024
More from Vitrolife Sweden AB
View all
K243373
· MQF · Jul 2025
K241662
· ITX · Aug 2024
K240605
· MQL · Aug 2024
K202862
· MQL · May 2021
K183486
· MQL · Jul 2019