510(k) · Cleared
Recalled · Class III · 2021Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hamilton Medical AG · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Sep 20, 2017 as substantially equivalent to K152029 (Hamilton Medical AG, 2016) after a 303-day review. Its family tree reaches back 8 generations to 1992. It has been recalled once.
- Decided
- Sep 20, 2017
- Review
- 303 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K913368 (1992). 12 ancestors in all, the oldest K902506 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 7 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 6 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 5 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 4 generations backK034026 RT 138 & RT 141 Dual-Heated Neonatal Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2005
- 3 generations backK103767 Dual Heated Infant Vreathing CirouitsFisher & Paykel Healthcare, Ltd. · 2012
- 2 generations backK122432 Adult Evaqua 2' Dual Heated Breathing CircuitsFisher & Paykel Healthcare, Ltd. · 2012
- 1 generation backK152029 Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010…Hamilton Medical AG · 2016
- This deviceK163283 Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010Hamilton Medical AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −7 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −6 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −5 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −4 | K034026 | RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −3 | K103767 | Dual Heated Infant Vreathing Cirouits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| −2 | K122432 | Adult Evaqua 2' Dual Heated Breathing Circuits | Fisher & Paykel Healthcare, Ltd. | 2012 | — |
| −1 | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010… | Hamilton Medical AG | 2016 | — |
| 0 (this device) | K163283 | Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 | Hamilton Medical AG | 2017 | — |
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 BTT? 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 BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 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 |
|---|---|---|---|
| * | K152029 | Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010Summary page 5…Page 5 === III. Predicate Device(s) Predicate Device for Humidifier Hamilton Medical AG HAMILTON-H900, respiratory gas humidifier, K152029 Predicate Devices for Heated Breathing Circuits Hamilton Medical AG HAMILTON-BC8010 and HAMILT… | 2016 |
| † | K983112 | Respiratory Humidifier, Model # MR850 | 1998 |
| † | K103767 | Dual Heated Infant Vreathing Cirouits | 2012 |
| † | 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2021 | Class III | Z-1385-2022 | Employee error | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, 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 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room. The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications. The HAMILTON-BC8010 breathing set is intended…
Read the full statement (118 words)
The HAMILTON-H900 humidifier is intended to add moisture and to warm breathing gases during invasive and non-invasive mechanical ventilation. The intended area of use is the intensive care ward or the recovery room.
The HAMILTON-H900 humidifier is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.
The HAMILTON-BC4010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163283 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163283: Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163283
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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