# K221127: Sientra, inc. Portfinder

- Pathway: 510(k) (Traditional)
- Applicant: Sientra, Inc.
- Decided: May 10, 2023 after 387 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905484 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963066: Mentor Injection Port Detector (Ipd), Mentor Corp. (1996) Summary page 4.

## Indications for use
The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders. The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system. The enclosed device is nonsterile and for postoperative use only.

Source page: https://510kreport.com/device/K221127
Methodology: https://510kreport.com/methodology