510(k) · Cleared
ClearedCompumedics Summit IP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compumedics USA, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Apr 23, 2004 as substantially equivalent to K013905 (Pro-Tech Services, Inc., 2002) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 2000. 13 later devices descend from it.
- Decided
- Apr 23, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000068 (2000). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000068 Compumedics E-Series Eeg SystemCompumedics Neuro Science Pty, Ltd. · 2000 · Recalled
- 1 generation backK021176 Compumedics Somte SystemCompumedics Limited · 2003
- This deviceK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- Descendant · cites it directly · 10 of its ownK043132 Universal XacttraceMedcare Flaga · 2004
- Descendant · 2 generations on · 7 of its ownK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- Descendant · 4 generations on · 2 of its ownK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 5 generations on · 1 of its ownK243966 FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K043132Universal XacttraceMedcare Flaga · 2004 · cites it directly10descendants
- K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc. · 2009 · 2 generations on7descendants
- K151940Thora-3Di, Model T-01Pneumacare Limited · 2016 · 3 generations on3descendants
- K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025 · 4 generations on2descendants
- K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000068 | Compumedics E-Series Eeg System | Compumedics Neuro Science Pty, Ltd. | 2000 | 1 |
| −1 | K021176 | Compumedics Somte System | Compumedics Limited | 2003 | — |
| 0 (this device) | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| +1 | K043132 | Universal Xacttrace | Medcare Flaga | 2004 | — |
| +2 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| +3 | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | — |
| +4 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025 | — |
| +5 | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K013905 | Modification EZ-1 System Repiratory SensorsSummary page 1…equivalent to: Device name: Synchrony"' summing amplifier Supplier: Pro-Tech Services, Inc. 510(k) number: K013905 The sensors used by the Summit IP are identical to those used by the respiratory effort part of the Compum… | 2002 |
| * | K021176 | Compumedics Somte SystemSummary page 1…Compumnedics Somt6 System. Device name: Compumedics Somtb System Supplier: Compurnedics Limited 510(k) number: K021176 3. Description of the Device The Compumnedics Summit IP consists of a small plastic enclosure with two input… | 2003 |
What descends from it? (13)
See all 132 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K043132 (Medcare Flaga, 2004) has gone furthest, with 10 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 | — |
What is it indicated for?
The Summit IP is intended for use in private practices or hospital environments for the detection of human respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. Signals from patient worn thoracic and abdominal sensors are demodulated, amplified and summed to provide electrical signals suitable for connection to the inputs of physiological recording equipment.
The Summit IP is only to be used under the direction and supervision of a physician.
The Summit IP unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The Summit IP unit is not intended for use on infant or pediatric patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040194 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040194: Compumedics Summit IP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040194
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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