510(k) · Cleared
ClearedThera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Oct 20, 2010 as substantially equivalent to K071958 (Smiths Medical Asd, Inc., 2007) and 2 other predicates after a 449-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Oct 20, 2010
- Review
- 449 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K913368 (1992). 11 ancestors in all, the oldest K902506 (1991). 2 later devices descend from it, 1 citing it directly.
- 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 backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- This deviceK092256 Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075…Smiths Medical Asd, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK122705 Humicare D900Grundler GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK133766 Humicare D900Gruendler GmbH · 2014
Most influential descendants
Showing 2 of 2 · See allView 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 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| 0 (this device) | K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 | Smiths Medical Asd, Inc. | 2010 | — |
| +1 | K122705 | Humicare D900 | Grundler GmbH | 2013 | — |
| +2 | K133766 | Humicare D900 | Gruendler GmbH | 2014 | — |
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 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071958 | Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator…Summary page 1…Gas Heater (21 CFR 868.5450, Product Code BflT) & Breathing System (21 CFR 868.5270, Product Code BZE) Predicate Device(s): * K07 1958,IThera-HeatTM Heated Humidifier, model RC70000, and Adult Heated Wire Ventilator Breathing Circuits, models, RC70050 and RC7005… | 2007 |
| * | K073706 | Respiratory Humidifier, Model MR850Summary page 1…) Predicate Device(s): * K07 1958,IThera-HeatTM Heated Humidifier, model RC70000, and Adult Heated Wire Ventilator Breathing Circuits, models, RC70050 and RC70052 * K(073706, (Fisher & Paykel Healthcare) models RTI30 and RT131 High Performance Circuits * K(913368, (Fisher & Paykel Electronics Ltd.) m… | 2008 |
| Kept off the family tree | K091368 | FDA’s K091368 is R2 Digitalnow HD (Digitalnow HD) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing CircuitsSummary page 1…are) models RTI30 and RT131 High Performance Circuits * K(913368, (Fisher & Paykel Electronics Ltd.) models MR700IMR72O/MR730 Dual Servo Respiratory Humidifier ACC • K000697, Allegiance Healthcare Corporation a subsidiaty of Cardinal Health, Inc, Airlifeo Heated Ventilator and Anesthesia Breathing Ci… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122705 | Humicare D900 | 2013 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K122705 (Grundler GmbH, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K071958.
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. 2010, 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 Smiths Medical Thera-Heat™ Heated Humidifier is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers. Inspiratoryheated…
Read the full statement (199 words)
The Smiths Medical Thera-Heat™ Heated Humidifier is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
Inspiratoryheated limb
A Neonate Ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
Inspiratory and Expiratory heated limb
A Neonate Heated Wire Ventilator Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092256: Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092256
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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