510(k) · Cleared
ClearedFisher & Paykel Healthcare Bubble Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 8, 2010 as substantially equivalent to K974176 (Drager, Inc., 1998) after a 277-day review. Its family tree reaches back 2 generations to 1991. 1 of the 7 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Oct 8, 2010
- Review
- 277 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902859 (1991). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
- This deviceK100011 Fisher & Paykel Healthcare Bubble Cpap SystemFisher & Paykel Healthcare, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK221436 F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK143700 CPAP CannulaideSalter Labs · 2015
- Descendant · cites it directly · 0 of its ownK131502 Seattle - PapSeattle Childrens Hospital · 2013 · Recalled (Class I)
Class I recalls in this family
- K131502 Seattle - Papcites it directly · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −1 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
| 0 (this device) | K100011 | Fisher & Paykel Healthcare Bubble Cpap System | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| +1 | K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023 | — |
| +1 | K143700 | CPAP Cannulaide | Salter Labs | 2015 | — |
| +1 | K131502 | Seattle - Pap | Seattle Childrens Hospital | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2023 | 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 BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K974176 | Babylog 8000 PlusSummary page 1…IPPB) Product Code: 73 BZD Regulation: 21 CFR 868.5905 Device Class: Class 2 Predicate Device: Product Name: Babylog 8000 plus ventilator (CPAP mode) 510(k) Number: K974176 Manufacturer: Drager Medical Product Code: 73 CBK Device Class: Class 2 Device Description: The Fisher & Paykel Healthcare (F&P… | 1998 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K131502Seattle - PapSeattle Childrens Hospital · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K221436 (Fisher & Paykel Healthcare, Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K974176.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The Fisher & Paykel Healthcare Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired and is prescribed by a physician.
The Bubble CPAP System is for use in the hospital clinical environment such as the NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit).
The intended patient population is premature and full term neonates up to a weight of 10 kg.
All components of the Bubble CPAP System are single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100011: Fisher & Paykel Healthcare Bubble Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100011
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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