# K041473: Var-Plus (Vortran Automatic Resuscitator), Model PCM

- Pathway: 510(k) (Traditional)
- Applicant: Vortran Medical Technology 1, Inc.
- Decided: Jul 15, 2004 after 43 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944349 (1995). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973975: Respirtechpro, Vortran Medical Technology 1, Inc. (1998) Summary page 1.
- K001430: Respirtech Pro-O2C, Model 2200 and Respirtech Pro, Model 2000, Vortran Medical Technology 1, Inc. (2000) Summary page 1.
- K944349: Oxylator EM-100, Cpr Medical Devices, Inc. (1995) Summary page 1.

## Most influential descendants
- K162968: Vortran GO2VENT (2017), 1 descendant of its own
- K073261: Var Monitor (2008), 1 descendant of its own
- K202219: VORTRAN GO2VENT with PEEP Valve (2021), 0 descendants of its own
- K103639: Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)- Pediatric (2011), 0 descendants of its own

## Recalls of this device
- Apr 20, 2017 · Class II · Z-2091-2017: Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread 
- Apr 20, 2017 · Class II · Z-2092-2017: Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread 

## Indications for use
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

Source page: https://510kreport.com/device/K041473
Methodology: https://510kreport.com/methodology