510(k) · Cleared
ClearedRescontrol II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jun 3, 2004 as substantially equivalent to K961783 (Resmed, Ltd., 1996) after a 52-day review. Its family tree reaches back 1 generation to 1996. 5 later devices descend from it.
- Decided
- Jun 3, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961783 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961783 Sullivan Vpap II ST Nasal Vpap SystemResmed, Ltd. · 1996
- This deviceK040944 Rescontrol IIResmed, Ltd. · 2004
- Descendant · cites it directly · 3 of its ownK072615 TxcontrolResmed, Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK092026 Easycare TX, TX LinkResmed, Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK113780 Easycare TX System (Connexuns)Resmed, Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK241939 EasyCare Tx 2Resmed Corp · 2024
- Descendant · cites it directly · 0 of its ownK063501 Knightcontrol Remote Control, Model M-114700-USMallinckrodt Developpement France · 2007
Most influential descendants
Showing 5 of 5 · See all- K072615TxcontrolResmed, Ltd. · 2008 · cites it directly3descendants
- K092026Easycare TX, TX LinkResmed, Ltd. · 2009 · cites it directly2descendants
- K113780Easycare TX System (Connexuns)Resmed, Ltd. · 2012 · 2 generations on1descendant
- K241939EasyCare Tx 2Resmed Corp · 2024 · 3 generations on0descendants
- K063501Knightcontrol Remote Control, Model M-114700-USMallinckrodt Developpement France · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961783 | Sullivan Vpap II ST Nasal Vpap System | Resmed, Ltd. | 1996 | — |
| 0 (this device) | K040944 | Rescontrol II | Resmed, Ltd. | 2004 | — |
| +1 | K072615 | Txcontrol | Resmed, Ltd. | 2008 | — |
| +1 | K092026 | Easycare TX, TX Link | Resmed, Ltd. | 2009 | — |
| +2 | K113780 | Easycare TX System (Connexuns) | Resmed, Ltd. | 2012 | — |
| +3 | K241939 | EasyCare Tx 2 | Resmed Corp | 2024 | — |
| +1 | K063501 | Knightcontrol Remote Control, Model M-114700-US | Mallinckrodt Developpement France | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 12 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 |
|---|---|---|---|
| * | K961783 | Sullivan Vpap II ST Nasal Vpap SystemSummary page 1…ator (with accessory) ' Proopietara Name ResContro]l II Predicate Device(s) ResMed UCU (K961783) Reason for submission New Device Indications for Use The ResControl Mis intended to be used by c… | 1996 |
| † | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | 1997 |
What descends from it? (5)
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?
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040944: Rescontrol II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040944
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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