# K003938: Trak Back II

- Pathway: 510(k) (Special)
- Applicant: Jomed, Inc.
- Decided: Jan 18, 2001 after 29 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 13, 2014 · Class II · Z-2636-2014: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

Source page: https://510kreport.com/device/K003938
Methodology: https://510kreport.com/methodology