# K123957: Pneupac Parapac Plus

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical International, Ltd.
- Decided: Sep 16, 2013 after 269 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 7 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801883 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020899: Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200D, Pneupac, Ltd. (2002) Summary page 2.
- K051469: Carevent Atv+ and Carevent Mri, O-Two Medical Technologies, Inc. (2005) Summary page 3.
- K013884: Boussignac C.P.a.P. Device, Vygon SA (2003) Summary page 2.
- K080256: Pulmodyne CHF Flow Generator System, Pulmodyne (2008) Summary page 2.

## Recalls of this device
- May 31, 2024 · Class I · Z-3090-2024: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation functi
- May 31, 2024 · Class I · Z-3091-2024: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation functi
- May 31, 2024 · Class I · Z-2974-2024: There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- May 31, 2024 · Class I · Z-2973-2024: There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- Feb 7, 2024 · Class I · Z-1274-2024: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breat
- Feb 7, 2024 · Class I · Z-1275-2024: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breat
- Jul 15, 2021 · Class III · Z-0163-2022: Two devices were labeled with the same serial number

## Indications for use
The Pneupace paraPAC plusTm Model 300/310 Ventilators are gas-powered emergency and transport portable ventilators that are primarily intended for use in transport applications in vehicles including fixed and rotary winged aircraft. They are suitable for emergency use at the accident scene, intra and inter-hospital transport and within medical facilities including medical imaging systems to 3 Teslas. They should only be used under the constant supervision or'trained healthcare professionals. The devices are intended to provide ventilatory support to adults, children and infants (above approx. 10kg). The devices also provide free flow oxygen therapy and CPAP therapy for spontaneously breathing patients.

Source page: https://510kreport.com/device/K123957
Methodology: https://510kreport.com/methodology