510(k) · Cleared
ClearedSleepflo, Model 101501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomec, Inc. · MNR Ventilatory Effort Recorder
Cleared on Aug 30, 2002 as substantially equivalent to K982293 (Pro-Tech Services, Inc., 1998) and 2 other predicates after a 186-day review. Its family tree reaches back 2 generations to 1992. 99 later devices descend from it.
- Decided
- Aug 30, 2002
- Review
- 186 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K913396 (1992). 4 ancestors in all. 99 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 1 generation backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- This deviceK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- Descendant · cites it directly · 98 of its ownK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- Descendant · 2 generations on · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
- Descendant · 3 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
- Descendant · 2 generations on · 31 of its ownK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K030379Aplab, Model 801D0030Sector Medical Corp. · 2003 · cites it directly98descendants
- K041904Compass F10 SystemMedcare Flaga · 2004 · 2 generations on54descendants
- K073682Embletta GoldEmbla Systems, Inc. · 2008 · 3 generations on41descendants
- K041724Compass M10 SystemMedcare Flaga · 2004 · 2 generations on41descendants
- K040576Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −1 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| 0 (this device) | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| +1 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| +2 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| +3 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| +2 | K041724 | Compass M10 System | Medcare Flaga | 2004 | — |
| +2 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 6 | 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), 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 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? (3)
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 |
|---|---|---|---|
| * | K982293 | Pressure Transducer Airflow SensorSummary page 1…Pro-Tech Pressure Transducer Airflow Sensor 51O(k) Number: K982293 Pro-Tech SPI Sensor… | 1998 |
| * | K940013 | Body Position Indicator, Model BPI1Summary page 1…51O(k) Number: K982293 Pro-Tech SPI Sensor 51O(k) Number: K940013 Pro-Tech Crystal Trace@ Piezo… | 1995 |
| * | K923402 | Crystal Trace Piezo Respiratory Effort SensorSummary page 1…Crystal Trace@ Piezo Respiratory Effort Sensor 510(k) Number: K923402 BIOMEC Inc., 1771 East 30th Street, Cleveland, Ohio 441 14 U.S.A. Telephone: 2 16 / 937-2800 Facsimile: 2… | 1992 |
What descends from it? (99)
See all 991 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030379 | Aplab, Model 801D0030 | 2003 | 98 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030379 (Sector Medical Corp., 2003) has gone furthest, with 98 descendants of its own.
- 3 other devices also cite its predicate K982293.
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 | — |
What is it indicated for?
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020607: Sleepflo, Model 101501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020607
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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