510(k) · Cleared
Recalled · Class I · 2019Neonatal ConchaSmart Breathing Circuits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Cleared on Aug 2, 2018 as substantially equivalent to K103767 (Fisher & Paykel Healthcare, Ltd., 2012) after a 290-day review. Its family tree reaches back 6 generations to 1992. 1 of the 11 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Aug 2, 2018
- Review
- 290 days
- Class
- Class II
- Product code
- BZE
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913368 (1992). 10 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 4 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 3 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 2 generations backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- 1 generation backK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- This deviceK173280 Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −5 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −4 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −3 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −2 | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −1 | K103767 | Dual Heated Infant Vreathing Cirouits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| 0 (this device) | K173280 | Neonatal ConchaSmart Breathing Circuits | Teleflexmedical, Inc. | 2018 | — |
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.
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 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? (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 |
|---|---|---|---|
| * | K103767 | Dual Heated Infant Vreathing CirouitsSummary page 4…ification Panel: Anesthesiology E. Predicate Device The Neonatal ConchaSmart Breathing Circuits are substantially equivalent to the following devices: • K103767 - RT265 and RT266 Dual Heated Infant Breathing Circuits In addition, the following devices are used as reference devices as d… | 2012 |
| † | K140556 | Conchasmart Breathing Circuit | 2014 |
| † | K151959 | AirLife Infant Single Limb Heated Wire Circuit | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2019 | Class I | Z-1912-2019 | Process control | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 5 other devices also cite its predicate K103767.
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. 2018, 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?
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients in professional healthcare environments as a conduit for respiratory gas between a patient and a ventilator or Infant Flow Generator (for single limb configuration) and include heated wire(s) for use with the Hudson RCI Neptune Heated Humidifier. The heated wires are intended to aid in maintaining the set patient temperature and minimize condensation in the ventilator tubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173280: Neonatal ConchaSmart Breathing Circuits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173280
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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