# K240389: Secret Line up (FCL18100C160  FCL19100E160 FCL1990E150  FCL2190G150 ); i-Thread (FCL18100C160  FCL19100E160 FCL1990E150  FCL2190G150)

- Pathway: 510(k) (Traditional)
- Applicant: Hyundae Meditech Co., Ltd.
- Decided: Mar 27, 2024 after 48 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K014153 (2002). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172602: Miracu, Feeltech Co., Ltd. (2018) Summary page 5.
- K220549: MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014, Hans Biomed Corporation (2023) Summary page 6.

## Most influential descendants
- K242571: Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (2024), 0 descendants of its own

## Indications for use
Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and supporting tissues and is intended for dermatological use only.

Source page: https://510kreport.com/device/K240389
Methodology: https://510kreport.com/methodology