# K200248: Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

- Pathway: 510(k) (Traditional)
- Applicant: Allwin Medical Devices, Inc.
- Decided: Jul 1, 2020 after 152 days
- Product code: MQF (Catheter, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Allwin ETC include the following models: Embryo Trans, Echo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, Pro Echo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter. Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure. Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Echo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter. Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.

Source page: https://510kreport.com/device/K200248
Methodology: https://510kreport.com/methodology