510(k) · Cleared
ClearedHC1000P Sleep Diagnosis Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hypnocore, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Apr 18, 2008 as substantially equivalent to K041904 (Medcare Flaga, 2004) and 1 other predicate after a 149-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Apr 18, 2008
- Review
- 149 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913396 (1992). 33 ancestors in all, the oldest K873535 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 4 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 3 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 2 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 1 generation backK041904 Compass F10 SystemMedcare Flaga · 2004
- This deviceK073269 HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −4 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −3 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −2 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −1 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| 0 (this device) | K073269 | HC1000P Sleep Diagnosis Software System | Hypnocore, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K041904 | Compass F10 System | 2004 |
| * | K070326 | Noga Automated Sleep Study Scoring and Data Management SystemSummary page 1…System. 3. Predicate Device: Compass Fl10 System (KO41 904) Noga Automated Sleep Study Scoring and Data Management System (K070326) 4. Description: HypnoCore's HC1000P is a sleep diagnosis software application. This software is… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 33 ancestors has a recall of any class.
- 3 other devices also cite its predicate K041904.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
HC1000P software analyzes ECG and pulse oxygen saturation data acquired from a sleeping patient. It may be used as an aid in the diagnosis of sleep and sleep related breathing disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073269: HC1000P Sleep Diagnosis Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073269
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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