# K965222: Microject Model Pca-1

- Pathway: 510(k) (Traditional)
- Applicant: Microject, Inc.
- Decided: Jun 19, 1997 after 170 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052221: Ambit Push & Play Ambulatory Infusion Pump (2005), 0 descendants of its own

## Indications for use
The indications for use of the MicroJect Model PCA-1 Driver is in the field of pain manggement. The Driver and associated, sterile Cassettes have been designed for the infusion of medications which are used to control pain. In addition to use by health care professionals, it is also indicated to be used by the patient for infusion of pain medications on an as-needed basis (patient controlled analgesia). The system is indicated for infusion of pain medications into intravenous, subcutaneous, and epidural access routes from standard drug containers, including flexible solution bags and syringes.

Source page: https://510kreport.com/device/K965222
Methodology: https://510kreport.com/methodology