510(k) · Cleared
Recalled · Class I · 2024Pneupac Parapac Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical International, Ltd. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Sep 16, 2013 as substantially equivalent to K020899 (Pneupac, Ltd., 2002) and 3 other predicates after a 269-day review. Its family tree reaches back 3 generations to 1980. 1 of the 12 devices in its family, counting itself, has a Class I recall. It has been recalled 7 times, including 6 Class I recalls.
- Decided
- Sep 16, 2013
- Review
- 269 days
- Class
- Class II
- Product code
- BTL
- Recalls
- 7 (6 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K801883 (1980). 11 ancestors in all. No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK801883 Peep Face MaskVital Signs, Inc. · 1980
- 2 generations backK982283 Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500…Caradyne, Ltd. · 1999
- 1 generation backK013884 Boussignac C.P.a.P. DeviceVygon SA · 2003
- This deviceK123957 Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801883 | Peep Face Mask | Vital Signs, Inc. | 1980 | — |
| −2 | K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow… | Caradyne, Ltd. | 1999 | — |
| −1 | K013884 | Boussignac C.P.a.P. Device | Vygon SA | 2003 | — |
| 0 (this device) | K123957 | Pneupac Parapac Plus | Smiths Medical International, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020899 | Parapac 200 Medic, Model P200, & Parapac 200D Medic, Model P200DSummary page 2…vices for Pneupae® paraPAC plusTM Model 300/3 10 510(k) Ventilators Smiths Medical Pneupac® Parapac® P200D Medic Ventilator K020899 0 Two Carevent System ATV+ KO051469 Predicate Devices for Pneupac® para… | 2002 |
| * | K051469 | Carevent Atv+ and Carevent MriSummary page 3…essure (CPAP) control to provide CPAP therapy for spontaneously breathing patients which is also one of the features of the predicate device, the 0 Two Carevent Systems (K05 1469). This is achieved by connecting a Pneupac® paraPAd plusT l Disposable CPAP Circuit to the Pneupac® paraPAC plUSTM Mode! 310 Vent… | 2005 |
| * | K013884 | Boussignac C.P.a.P. DeviceSummary page 2…CPAP Circuit _____ Vygon Boussignac CPAP Device K013884 Pulmodyrie CHF Flow Generation System K080256 Device Description: The Pneupac® par… | 2003 |
| * | K080256 | Pulmodyne CHF Flow Generator SystemSummary page 2…Vygon Boussignac CPAP Device K013884 Pulmodyrie CHF Flow Generation System K080256 Device Description: The Pneupac® paraPAC plusT"l Model 300/3 10 Ventilators are gas powered portable medical devices intended… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2024 | Class I | Z-3090-2024 | Other | 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. |
| May 31, 2024 | Class I | Z-3091-2024 | Other | 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. |
| May 31, 2024 | Class I | Z-2974-2024 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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… |
| Feb 7, 2024 | Class I | Z-1275-2024 | Under Investigation by firm | 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… |
| Jul 15, 2021 | Class III | Z-0163-2022 | Process control | Two devices were labeled with the same serial number |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- None of the 11 ancestors has a recall.
- 1 other device also cites its predicate K020899.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (99 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123957: Pneupac Parapac Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123957
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026