510(k) · Cleared
ClearedFlexicare Neonatal Heated Wire Breathing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical Limited. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Jun 23, 2016 as substantially equivalent to K034026 (Fisher & Paykel Healthcare, Ltd., 2005) and 1 other predicate after a 118-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jun 23, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- BZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913368 (1992). 9 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 4 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 3 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 2 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 1 generation backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- This deviceK160540 Flexicare Neonatal Heated Wire Breathing SystemFlexicare Medical Limited. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −4 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −3 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −2 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −1 | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| 0 (this device) | K160540 | Flexicare Neonatal Heated Wire Breathing System | Flexicare Medical Limited. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 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 BZE? 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 BZE device
- #1 K252066 inspired™ Heated Breathing Circuit (510-008)…score 13.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsSummary page 5…alent Device: Flexicare’s Neonatal Heated Wire Breathing Systems are substantially equivalent to Fisher & Paykel’s Neonatal RT235 Heated Breathing Circuit cleared under K034026. Flexicare’s Autofill Humidification Chamber is substantially equivalent to Fisher & Paykel’s MR290 Autofill Humidification cham… | 2005 |
| * | K934140 | MR290 Humidification Chamber Single UseSummary page 5…cleared under K034026. Flexicare’s Autofill Humidification Chamber is substantially equivalent to Fisher & Paykel’s MR290 Autofill Humidification chamber cleared under K934140. Device Description: Flexicare Neonatal Heated Wire Breathing Systems are sterile single patient use devices which form part o… | 1994 |
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 24 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K034026.
How does its category compare?
All BZE devicesBZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · BZE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZE
241in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZE
No recall names BZE since 2007.
Adverse event reports per year · BZE
193in 2025
MAUDE reports naming product code BZE, 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 | 0 | — | 0 | 69 |
| 2008 | 0 | — | 0 | 74 |
| 2009 | 0 | — | 0 | 80 |
| 2010 | 2 | — | 0 | 126 |
| 2011 | 1 | — | 0 | 192 |
| 2012 | 2 | — | 0 | 334 |
| 2013 | 0 | — | 0 | 387 |
| 2014 | 1 | — | 0 | 338 |
| 2015 | 1 | — | 0 | 155 |
| 2016 | 5 | 241 | 0 | 214 |
| 2017 | 1 | — | 0 | 209 |
| 2018 | 1 | — | 0 | 103 |
| 2019 | 0 | — | 0 | 134 |
| 2020 | 0 | — | 0 | 123 |
| 2021 | 1 | — | 0 | 124 |
| 2022 | 0 | — | 0 | 152 |
| 2023 | 1 | — | 0 | 125 |
| 2024 | 2 | — | 0 | 172 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Flexicare Neonatal Heated Wire Breathing Systems are intended for use to connect a patient’s airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min.
Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
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/K160540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160540: Flexicare Neonatal Heated Wire Breathing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160540
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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