510(k) · Cleared
ClearedMR620 Dual Servo Heated Anaesthesia Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Allied Products, Ltd. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Sep 23, 1986 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Sep 23, 1986
- Review
- 53 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK862923 MR620 Dual Servo Heated Anaesthesia HumidifierFisher & Paykel Allied Products, Ltd. · 1986
- Descendant · cites it directly · 7 of its ownK092129 Intersurgical Heated Wire Breathing Systems and Humidification…Intersurgical, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK151461 Hybernite RTPlastiflex Group NV · 2016
- Descendant · 3 generations on · 2 of its ownK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK962223 Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K092129Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model…Intersurgical, Inc. · 2010 · cites it directly7descendants
- K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011 · 2 generations on3descendants
- K151461Hybernite RTPlastiflex Group NV · 2016 · 2 generations on2descendants
- K140424Respironics Reusable Heated TubingRespironics, Inc. · 2014 · 3 generations on2descendants
- K962223Water Chambers for ST 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862923 | MR620 Dual Servo Heated Anaesthesia Humidifier | Fisher & Paykel Allied Products, Ltd. | 1986 | — |
| +1 | K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model… | Intersurgical, Inc. | 2010 | — |
| +2 | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| +2 | K151461 | Hybernite RT | Plastiflex Group NV | 2016 | — |
| +3 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| +1 | K962223 | Water Chambers for ST 3000 Heated Humidifier | Marquest Medical Products, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K092129 (Intersurgical, Inc., 2010) has gone furthest, with 7 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K862923 · printed Nov 5, 2026
Cite this page
510(k) Report. “K862923: MR620 Dual Servo Heated Anaesthesia Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862923
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026