Pneupac Parapac Plus

510(k) K123957

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK123957	Date16 Sep 2013Cleared	StatusActive

7 recalls · 6 ongoing · FDA

2 recalls, same reason
- Ongoing Z-2973-2024 FDA Class I initiated 31 May 2024
- Ongoing Z-2974-2024 FDA Class I initiated 31 May 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.
2 recalls, same reason
- Ongoing Z-3091-2024 FDA Class I initiated 31 May 2024
- Ongoing Z-3090-2024 FDA Class I initiated 31 May 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 function.
2 recalls, same reason
- Ongoing Z-1275-2024 FDA Class I initiated 7 Feb 2024
- Ongoing Z-1274-2024 FDA Class I initiated 7 Feb 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 breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
- Terminated Z-0163-2022 FDA Class III initiated 15 Jul 2021
Two devices were labeled with the same serial number

1 jurisdiction

United States — FDA 510(k) Active

510(k)