510(k) · Cleared
ClearedUltima Body Position Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braebon Medical Corp. · LEL Device, Sleep Assessment
Cleared on Aug 20, 1998 as substantially equivalent to K940013 (Pro-Tech, Inc., 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Aug 20, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- LEL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923033 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K191492Maxxi Position SensorNeurovirtual USA, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923033 | The Tracker | Epm Information Systems, Inc. | 1993 | — |
| 0 (this device) | K981969 | Ultima Body Position Sensor | Braebon Medical Corp. | 1998 | — |
| +1 | K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LEL? 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 LEL device
- #1 K252981 EmbraceMiniscore 23.3 · 40 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 |
|---|---|---|---|
| * | K940013 | Body Position Indicator, Model BPI1Summary page 3…y or on the order of a physician. The Ultima Body Position Sensor is similar in design, function and intent as the legally marketed Sleep Position Indicator, Model BPI1, k940013; Mini-Tracker, k923033. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of… | 1995 |
| * | K923033 | The TrackerSummary page 3…physician. The Ultima Body Position Sensor is similar in design, function and intent as the legally marketed Sleep Position Indicator, Model BPI1, k940013; Mini-Tracker, k923033. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191492 | Maxxi Position Sensor | 2020 | 0 |
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 LEL devicesLEL Device, Sleep Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LEL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LEL
96in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LEL
No recall names LEL since 2007.
Adverse event reports per year · LEL
1in 2021
MAUDE reports naming product code LEL, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | 96 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BRAEBON MEDICAL CORPORATION Ultima Body Position Sensor™ is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a three-volt lithium battery and plugs directly into either a DC amplifier or multiplexer. The target population of the Ultima Body Position Sensor is all children and adult patients who are screened during sleep disorder studies. The majority of the screenings occur at a sleep laboratory…
Read the full statement (123 words)
The BRAEBON MEDICAL CORPORATION Ultima Body Position Sensor™ is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a three-volt lithium battery and plugs directly into either a DC amplifier or multiplexer.
The target population of the Ultima Body Position Sensor is all children and adult patients who are screened during sleep disorder studies. The majority of the screenings occur at a sleep laboratory although the sensor can also be used in home studies.
The Ultima Body Position Sensor is intended for use only by or on the order of a physician. The Ultima Body Position Sensor is similar in design, function and intent as the legally marketed Sleep Position Indicator, Model BPI1, k940013; Mini-Tracker, k923033.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981969: Ultima Body Position Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981969
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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