510(k) · Cleared
ClearedF&P 950 Accessory Breathing Circuit Kits
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 Jun 29, 2023 as substantially equivalent to K100011 (Fisher & Paykel Healthcare, Ltd., 2010) after a 408-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jun 29, 2023
- Review
- 408 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902859 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
- 1 generation backK100011 Fisher & Paykel Healthcare Bubble Cpap SystemFisher & Paykel Healthcare, Ltd. · 2010
- This deviceK221436 F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
| −1 | K100011 | Fisher & Paykel Healthcare Bubble Cpap System | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| 0 (this device) | K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 BZD? 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 |
|---|---|---|---|
| * | K100011 | Fisher & Paykel Healthcare Bubble Cpap SystemSummary page 4…assification BZD (21 CFR §868.5905) Product Code III. PREDICATE DEVICE Predicate device: 510(k) Number Device Name K100011 Bubble CPAP System (BC151/BC161) Reference Devices: 510(k) Number… | 2010 |
| † | K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | 2022 |
| † | K103767 | Dual Heated Infant Vreathing Cirouits | 2012 |
| † | K173770 | OJR215 Pressure Relief Manifold | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100011.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
950N60J – Bubble CPAP Dual Heated Circuit Kit The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is…
Read the full statement (209 words)
950N60J – Bubble CPAP Dual Heated Circuit Kit
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
950N62J – Bubble CPAP Dual Heated Circuit Kit (for Hudson interface)
The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended to provide heated and humidified CPAP to spontaneously breathing premature and full term neonates and infant patients (up to a weight of 10 kg) who require breathing support, due to conditions associated with prematurity (such as Respiratory Distress Syndrome) or other conditions where CPAP is required or desired. It is intended for use within a hospital clinical environment such as a NICU (Neonatal Intensive Care Unit) and PICU (Pediatric Intensive Care Unit), within the limits of its stated technical specifications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221436: F&P 950 Accessory Breathing Circuit Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221436
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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