510(k) · Cleared
ClearedRescan
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 May 5, 2004 as substantially equivalent to K024191 (Resmed, Ltd., 2003) after a 128-day review. Its family tree reaches back 3 generations to 1997. 21 later devices descend from it.
- Decided
- May 5, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971260 (1997). 5 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 2 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 1 generation backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- This deviceK034033 RescanResmed, Ltd. · 2004
- Descendant · cites it directly · 20 of its ownK050775 ResscanResmed, Ltd. · 2005
- Descendant · 2 generations on · 15 of its ownK113815 ResscanResmed, Ltd. · 2012
- Descendant · 2 generations on · 13 of its ownK082983 Resscan-ProResmed, Ltd. · 2009
- Descendant · 3 generations on · 12 of its ownK093684 Easycare OnlineResmed, Ltd. · 2010
- Descendant · 3 generations on · 10 of its ownK140054 RescanResmed, Ltd. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K050775ResscanResmed, Ltd. · 2005 · cites it directly20descendants
- K113815ResscanResmed, Ltd. · 2012 · 2 generations on15descendants
- K082983Resscan-ProResmed, Ltd. · 2009 · 2 generations on13descendants
- K093684Easycare OnlineResmed, Ltd. · 2010 · 3 generations on12descendants
- K140054RescanResmed, Ltd. · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −2 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −1 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| 0 (this device) | K034033 | Rescan | Resmed, Ltd. | 2004 | — |
| +1 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| +2 | K113815 | Resscan | Resmed, Ltd. | 2012 | — |
| +2 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| +3 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| +3 | K140054 | Rescan | Resmed, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K024191 | S7 Elite and Autoset Spirit Cpap Systems with ReslinkSummary page 1…evice Common Name/ Data download and display software Classification Name: Predicate Devices: AutoScan TM software (K024191) Device Description: The ResScan software with its capabilities of data collection and display of… | 2003 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050775 | Resscan | 2005 | 20 |
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 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K050775 (Resmed, Ltd., 2005) has gone furthest, with 20 descendants of its own.
- 4 other devices also cite its predicate K024191.
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 ResScan software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan is used to download and view therapy data, as well as store therapy information and print reports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K034033: Rescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K034033
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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