PNEUPAC PARAPAC PLUS— 510(k) K123957
Substantially EquivalentSmiths Medical International , Ltd.
FDA 510(k) clearance K123957 for PNEUPAC PARAPAC PLUS, Substantially Equivalent on 2013-09-16. Applicant: Smiths Medical International , Ltd.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical International , Ltd.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luton, Bedfordshire, GB
Recent devices under product code BTL
view allMore clearances from Smiths Medical International , Ltd.
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K123957
K-number listed on FDA's recall record- Z-2973-2024 — Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
- Z-2974-2024 — Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
- Z-3090-2024 — paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
- Z-3091-2024 — paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
- Z-1274-2024 — smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
- Z-1275-2024 — smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
- Z-0163-2022 — Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123957.
Data sourced from openFDA. This site is unofficial and independent of the FDA.