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 16, 2014 as substantially equivalent to K113815 (Resmed, Ltd., 2012) after a 127-day review. Its family tree reaches back 7 generations to 1997. 10 later devices descend from it.
- Decided
- May 16, 2014
- Review
- 127 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K971260 (1997). 13 ancestors in all, the oldest K930656 (1994). 10 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 5 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 4 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 3 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 2 generations backK050775 ResscanResmed, Ltd. · 2005
- 1 generation backK113815 ResscanResmed, Ltd. · 2012
- This deviceK140054 RescanResmed, Ltd. · 2014
- Descendant · cites it directly · 4 of its ownK152356 SapphireRespironics, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK151901 AirViewResmed, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK253553 OrionResmed Corp · 2026
- Descendant · cites it directly · 0 of its ownK252802 Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K152356SapphireRespironics, Inc. · 2016 · cites it directly4descendants
- K181053Care OrchestratorRespironics, Inc. · 2019 · 2 generations on1descendant
- K151901AirViewResmed, Ltd. · 2015 · cites it directly1descendant
- K253553OrionResmed Corp · 2026 · cites it directly0descendants
- K252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −6 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −5 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −4 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −3 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −2 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −1 | K113815 | Resscan | Resmed, Ltd. | 2012 | — |
| 0 (this device) | K140054 | Rescan | Resmed, Ltd. | 2014 | — |
| +1 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| +2 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
| +1 | K151901 | AirView | Resmed, Ltd. | 2015 | — |
| +1 | K253553 | Orion | Resmed Corp | 2026 | — |
| +1 | K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K113815 | ResscanSummary page 1…21 CFR 868.5895, 73 CBK (Class 11) Ventilator, continuous, facility use Legally Marketed ResScan (K113815) Predicate Device Reason for Submission New Device Indication for Use ResScan is intended to augment… | 2012 |
What descends from it? (10)
6 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K152356 (Respironics, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K113815.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ResScan is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information. This includes the ability to remotely change settings in non-life support devices only.
It is intended to be used by Clinicians in conjunction with ResMed compatible therapy devices, using ResMed's proprietary communications protocol.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140054: Rescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140054
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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