510(k) · Cleared
ClearedBody Position Indicator, Model BPI1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Tech, Inc. · MNR Ventilatory Effort Recorder
Cleared on May 4, 1995 after a 485-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 102 later devices descend from it.
- Decided
- May 4, 1995
- Review
- 485 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
102 later devices descend from it, 2 citing it directly.
- This deviceK940013 Body Position Indicator, Model BPI1Pro-Tech, Inc. · 1995
- Descendant · cites it directly · 99 of its ownK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- Descendant · 2 generations on · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 3 generations on · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 4 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K020607Sleepflo, Model 101501Biomec, Inc. · 2002 · cites it directly99descendants
- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · 2 generations on98descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 3 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 4 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940013 | Body Position Indicator, Model BPI1 | Pro-Tech, Inc. | 1995 | — |
| +1 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| +2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +4 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +3 | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (102)
See all 1022 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?
- Of its descendants, K020607 (Biomec, Inc., 2002) has gone furthest, with 99 descendants of its own.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
https://510kreport.com/device/K940013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940013: Body Position Indicator, Model BPI1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940013
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026