# K981860: A P Harness

- Pathway: 510(k) (Traditional)
- Applicant: Paraworks Enterprise, Ltd.
- Decided: Jun 3, 1999 after 372 days
- Product code: KMK (Device, Intravascular Catheter Securement)
- Device class: 1
- Regulation: 21 CFR 880.5210
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Baxter’s SiteLock™ Epidural Catheter Securement Device: named in the summary without a submission number

## Indications for use
The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.

Source page: https://510kreport.com/device/K981860
Methodology: https://510kreport.com/methodology