# K042796: Endotine Transbleph 3.0/3.5 Device

- Pathway: 510(k) (Special)
- Applicant: Coapt Systems, Inc.
- Decided: Nov 5, 2004 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K014153 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040740: Endotine Transbleph Device, Coapt Systems, Inc. (2004) Summary page 2.
- 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 Devices”.
- K033524: Coapt Endotine Chin 3.5 Device, Coapt Systems, Inc. (2003) Summary page 2.

## Recalls of this device
- May 6, 2016 · Class II · Z-2294-2016: MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incor

## Indications for use
The ENDOTINE TransBleph is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.

Source page: https://510kreport.com/device/K042796
Methodology: https://510kreport.com/methodology