510(k) · Cleared
ClearedIspira Resuscitation Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoforce Group, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 7, 2009 as substantially equivalent to K892885 (Fisher & Paykel Electronics, Ltd., 1989) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1986. 4 later devices descend from it.
- Decided
- Oct 7, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K862830 (1986). 14 ancestors in all, the oldest K801883 (1980). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 3 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 2 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 1 generation backK080692 Macs Cpap SystemAiron Corporation · 2008
- This deviceK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142096 T-Piece ResuscitatorMercury Medical · 2014
- Descendant · 2 generations on · 0 of its ownK122627 Gio Digital Pressure GuagesGalemed Corp. · 2013
Most influential descendants
Showing 4 of 4 · See all- K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · cites it directly2descendants
- K110119Pressure ManometerNeoforce Group, Inc. · 2011 · cites it directly1descendant
- K142096T-Piece ResuscitatorMercury Medical · 2014 · cites it directly0descendants
- K122627Gio Digital Pressure GuagesGalemed Corp. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −3 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −2 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −1 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| 0 (this device) | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +1 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| +1 | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K142096 | T-Piece Resuscitator | Mercury Medical | 2014 | — |
| +2 | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
Planning a device in BTL? 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? (3)
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 |
|---|---|---|---|
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…Anesthesiology 21 CFR 868.5925 Ventilator, Emergency Power, BTL, Class II Performance Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Resuscitator K080692 Airon Corp, MACS CPAP K053140 Ambu, Mark IV 510(k) additional i… | 1989 |
| * | K080692 | Macs Cpap SystemSummary page 1…ilator, Emergency Power, BTL, Class II Performance Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Resuscitator K080692 Airon Corp, MACS CPAP K053140 Ambu, Mark IV 510(k) additional information 7 Oct 2009 Page… | 2008 |
| * | K053140 | Ambu Mark IV ResuscitatorSummary page 1…Performance Standards: None applicable Predicate Device: K892885 Fisher & Paykel, Neopuff Resuscitator K080692 Airon Corp, MACS CPAP K053140 Ambu, Mark IV 510(k) additional information 7 Oct 2009 Page 1 of2 Device Descript… | 2005 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K102649 (Neoforce Group, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K892885.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092085: Ispira Resuscitation Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092085
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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