# K944495: Model 3200 Vascular Mini-Lab

- Pathway: 510(k) (Traditional)
- Applicant: Parks Medical Electronics, Inc.
- Decided: Jun 2, 1995 after 262 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K093192: Flochec Photo Plethysmographic Device (2010), 1 descendant of its own
- K143094: QuantaFlo (2015), 0 descendants of its own

## Recalls of this device
- Aug 8, 2012 · Class II · Z-0443-2013: Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood p

Source page: https://510kreport.com/device/K944495
Methodology: https://510kreport.com/methodology