# K040740: Endotine Transbleph Device

- Pathway: 510(k) (Traditional)
- Applicant: Coapt Systems, Inc.
- Decided: May 10, 2004 after 49 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K014153 (2002). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014153: Coapt Systmes Endotine Device, Coapt Systems, Inc. (2002) Summary page 2.
- K023922: Coapt Systems Endotine Device, Model CFD-101-00197, Coapt Systems, Inc. (2002). Our reading of the summary gave K023992, FDA’s number for Wiener Lab Colinesterasa AA (Wiener Laboratories Saic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ENDOTINE Forehead Device”.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 2.
- K033524: Coapt Endotine Chin 3.5 Device, Coapt Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K060248: Ultratine Transbleph (2006), 0 descendants of its own
- K042796: Endotine Transbleph 3.0/3.5 Device (2004), 0 descendants of its own

## Indications for use
The ENDOTINE TransBlephTM Device is intended for use in subperiosteal browplasty fixation. The ENDOTINE TransBleph TM is specifically indicated for use to fixate the sub-dermis to the frontal bone.

Source page: https://510kreport.com/device/K040740
Methodology: https://510kreport.com/methodology