510(k) · Cleared
ClearedHumicare D900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grundler GmbH · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on May 21, 2013 as substantially equivalent to K073706 (Fisher & Paykel Healthcare, Ltd., 2008) and 3 other predicates after a 259-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- May 21, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K913368 (1992). 21 ancestors in all, the oldest K902506 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 6 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 5 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 4 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 3 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 1 generation backK092256 Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075…Smiths Medical Asd, Inc. · 2010
- This deviceK122705 Humicare D900Grundler GmbH · 2013
- Descendant · cites it directly · 0 of its ownK133766 Humicare D900Gruendler GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K133766Humicare D900Gruendler GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −6 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −5 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −4 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −3 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −1 | K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 | Smiths Medical Asd, Inc. | 2010 | — |
| 0 (this device) | K122705 | Humicare D900 | Grundler GmbH | 2013 | — |
| +1 | 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 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073706 | Respiratory Humidifier, Model MR850Summary page 1…900 Common name Respiratory Gas Humidifier Classification 21 CFR 868.5450 Product code 73 BTT Predicate Devices K073706, (Fisher & Paykel Healthcare) MR850 Respiratory Humidifier K092256, (Smiths Medical ASO Inc.) Thera-Heatm… | 2008 |
| * | K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Summary page 1…68.5450 Product code 73 BTT Predicate Devices K073706, (Fisher & Paykel Healthcare) MR850 Respiratory Humidifier K092256, (Smiths Medical ASO Inc.) Thera-Heatm Heated Humidifier K983112, (Fisher & Paykel Healthcare) Heated Tub… | 2010 |
| * | K983112 | Respiratory Humidifier, Model # MR850Summary page 1…Fisher & Paykel Healthcare) MR850 Respiratory Humidifier K092256, (Smiths Medical ASO Inc.) Thera-Heatm Heated Humidifier K983112, (Fisher & Paykel Healthcare) Heated Tubing RTI1O1 as part of MR850 Respiratory Humidifier… | 1998 |
| * | K100104 | Hybernite Rainout Control SystemSummary page 1…K983112, (Fisher & Paykel Healthcare) Heated Tubing RTI1O1 as part of MR850 Respiratory Humidifier K100104, (Plastiflex Group NV) Hybernite Rainout Control System Reason for submission New device Intended Use the Gr… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133766 | Humicare D900 | 2014 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K133766 (Gruendler GmbH, 2014) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K073706.
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. 2013, 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 GrOndler's HumiCare 0900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface. Healed breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient…
Read the full statement (108 words)
The GrOndler's HumiCare 0900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface.
Healed breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing. or eliminating water. They are accessories for the GrOndlers HumiCare 0900. The heated breathing circuits are used for flow rates greater than 3t/min.
The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122705: Humicare D900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122705
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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