510(k) · Cleared
ClearedEasycare TX, TX Link
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 Oct 2, 2009 as substantially equivalent to K072615 (Resmed, Ltd., 2008) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 2, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961783 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961783 Sullivan Vpap II ST Nasal Vpap SystemResmed, Ltd. · 1996
- 2 generations backK040944 Rescontrol IIResmed, Ltd. · 2004
- 1 generation backK072615 TxcontrolResmed, Ltd. · 2008
- This deviceK092026 Easycare TX, TX LinkResmed, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK113780 Easycare TX System (Connexuns)Resmed, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK241939 EasyCare Tx 2Resmed Corp · 2024
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 |
|---|---|---|---|---|---|
| −3 | K961783 | Sullivan Vpap II ST Nasal Vpap System | Resmed, Ltd. | 1996 | — |
| −2 | K040944 | Rescontrol II | Resmed, Ltd. | 2004 | — |
| −1 | K072615 | Txcontrol | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K092026 | Easycare TX, TX Link | Resmed, Ltd. | 2009 | — |
| +1 | K113780 | Easycare TX System (Connexuns) | Resmed, Ltd. | 2012 | — |
| +2 | K241939 | EasyCare Tx 2 | Resmed Corp | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072615 | TxcontrolSummary page 1…ame Non-continuous ventilator (IPPB) Proprietary Name EasyCare Tx System Predicate Device(s) TxControl (K072615) -, ResControl II (K040944) Reason for submission New Device Intende… | 2008 |
| * | K040944 | Rescontrol IISummary page 1…etary Name EasyCare Tx System Predicate Device(s) TxControl (K072615) -, ResControl II (K040944) Reason for submission New Device Intended Use The EasyCare Tx System comprises of the titration software,… | 2004 |
| † | K971813 | EMBLA | 1998 |
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 |
|---|---|---|---|
| K113780 | Easycare TX System (Connexuns) | 2012 | 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 13 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113780 (Resmed, Ltd., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link. EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel device setting changes remotely. EasyCare Tx is…
Read the full statement (135 words)
The EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link.
EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel device setting changes remotely.
EasyCare Tx is intended to be used in a clinical environment.
The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).
The Tx Link is intended to be used in a clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092026: Easycare TX, TX Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092026
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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