510(k) · Cleared
ClearedResubmitted RD1000 Neopuff Infant Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Electronics, Ltd. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 6, 1989 after a 170-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 27 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.
- Decided
- Oct 6, 1989
- Review
- 170 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 12 citing it directly. 6 of the 27 devices in this family, counting this one, have a Class I recall.
- This deviceK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
- Descendant · cites it directly · 10 of its ownK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK072021 Neopip Infant ResuscitatorNeoforce Group, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK070377 Giraffe and Panda WarmerOhmeda Medical · 2007 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK120642 Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · cites it directly10descendants
- K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · cites it directly4descendants
- K072021Neopip Infant ResuscitatorNeoforce Group, Inc. · 2007 · cites it directly3descendants
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on3descendants
- K120642Resuscitaire with AutobreathDraeger Medical Systems, Inc. · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892885 | Resubmitted RD1000 Neopuff Infant Resuscitator | Fisher & Paykel Electronics, Ltd. | 1989 | — |
| +1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| +1 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| +1 | K072021 | Neopip Infant Resuscitator | Neoforce Group, Inc. | 2007 | — |
| +2 | K070377 | Giraffe and Panda Warmer | Ohmeda Medical | 2007 | Class I |
| +1 | K120642 | Resuscitaire with Autobreath | Draeger Medical Systems, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2007 | 5 | 2 |
| 2009 | 2 | 1 |
| 2010 | 2 | 2 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 2612 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070210 | Giraffe and Panda T- Piece Resuscitation System Class I | 2007 | 10 |
| K092085 | Ispira Resuscitation Unit | 2009 | 4 |
| K072021 | Neopip Infant Resuscitator | 2007 | 3 |
| K120642 | Resuscitaire with Autobreath | 2012 | 2 |
| K102649 | Neopop Infant Resuscitator with Flow Meter | 2011 | 2 |
| K070416 | Neopeep Neonatal Resuscitation Circuit with Peep | 2007 | 2 |
| K140707 | Lifeborne Infant Resuscitator | 2014 | 1 |
| K093913 | Mercury Medical T-Piece Resuscitator Class I | 2010 | 1 |
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | 2025 | 0 |
| K102542 | Resusci Flow; Resusci Flow 104 | 2011 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 13 Class I recalls
- K070377Giraffe and Panda WarmerOhmeda Medical · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K123309Giraffe and Panda WarmersOhmeda Medical · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 13 Class I recalls
- K090697Modification to: Giraffe and Panda WarmerOhmeda Medical · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K070210 (Ohmeda Medical, 2007) has gone furthest, with 10 descendants of its own.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K892885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K892885: Resubmitted RD1000 Neopuff Infant Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K892885
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026