510(k) · Cleared
ClearedRemrest Heated Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Industries America, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on May 2, 2005 as substantially equivalent to K003973 (Fisher & Paykel Healthcare, Ltd., 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 2, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010263 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010263 Remstar Plus Cpap SystemRespironics, Inc. · 2001 · Recalled
- This deviceK050990 Remrest Heated HumidifierMedical Industries America, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010263 | Remstar Plus Cpap System | Respironics, Inc. | 2001 | 3 |
| 0 (this device) | K050990 | Remrest Heated Humidifier | Medical Industries America, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K003973 | Respiratory Humidifier, Model HC150Summary page 1…ory Gas (Direct Patient Interface) Predicate Devices: Respironics - RemnStar - KO 10263 Fisher & Paykel - tIC ISO - K003973 Device Description: The RemRest Heated I lumuidifier is a simple heated humidifier to be used with a CPAP device to provide hea… | 2001 |
| * | K010263 | Remstar Plus Cpap SystemSummary page 2…or patients requiring Continuous Positive Respironics - RemStar with Airway Pressure (CPAP) therapy for the humidifier - K010263 treatment of Obstructive Sleep Apnea. The addition of heated humidification to… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K003973.
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 | — |
What is it indicated for?
The [vo Heated Humidifier is intended to warm and add
moisture to the breathing gases for administration to a
patient. It is used for patients requiring Continuous
Positive Airway Pressure (CPAP) therapy for the treatment
of Obstructive Sleep Apnea. The addition of heated
humidification to tfis therapy relieves the drying and
irritating effects on the patient airways, which may arise
from the use of a CPAP system. Use only with RemiRest
900 series CPAP devices.
It is portable and is intended to be used in the home,
hospital, and institutional settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050990: Remrest Heated Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050990
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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