510(k) · Cleared
ClearedBreath Control (Breath Actuator), Sensitouch Breath Control, Head Array (Switch Head Control), Tri-Switch Head Array, HD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · ITI Wheelchair, Powered
Cleared on Nov 6, 1998 as substantially equivalent to K881463 (Dufco Electronics, Inc., 1988) after a 29-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881463 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK881463 Multimode (TM) Power Module SystemDufco Electronics, Inc. · 1988
- This deviceK983520 Breath Control (Breath Actuator), Sensitouch Breath Control, Head…Sunrise Medical, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK073330 Freedom Sciences Motion Control Module (MCM)Freedom Sciences, LLC · 2008
- Descendant · 2 generations on · 0 of its ownK091723 Freedom Sciences Motion Control Module Version 1.5Freedom Sciences, LLC · 2009
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 |
|---|---|---|---|---|---|
| −1 | K881463 | Multimode (TM) Power Module System | Dufco Electronics, Inc. | 1988 | — |
| 0 (this device) | K983520 | Breath Control (Breath Actuator), Sensitouch Breath Control, Head Array… | Sunrise Medical, Inc. | 1998 | — |
| +1 | K073330 | Freedom Sciences Motion Control Module (MCM) | Freedom Sciences, LLC | 2008 | — |
| +2 | K091723 | Freedom Sciences Motion Control Module Version 1.5 | Freedom Sciences, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 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 |
|---|---|---|---|
| * | K881463 | Multimode (TM) Power Module SystemSummary page 3…ate Device Desc. |Model # Current Current Invacare (Invacare In Sub- In Sub- Quickie Dufco Quickie Dufco [Model # [Device mission mission Description Model # Description K881463 K881463 Breath Breath Control SNPM4 Sip-N-Puff Actuator 2910 3365 N/A N/A Electronic Head 3519 ASL105C | Electronic Head Array Ar… | 1988 |
| * | — | Invacare devices listed in the predicate comparison table Named without a submission number |
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 |
|---|---|---|---|
| K073330 | Freedom Sciences Motion Control Module (MCM) | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K073330 (Freedom Sciences, LLC, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983520: Breath Control (Breath Actuator), Sensitouch Breath Control, Head Array (Switch Head Control), Tri-Switch Head Array, HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983520
Report an extraction error
Are you the manufacturer?
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