510(k) · Cleared
ClearedModification EZ-1 System Repiratory Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Tech Services, Inc. · MNR Ventilatory Effort Recorder
Cleared on Apr 22, 2002 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Apr 22, 2002
- Review
- 147 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK013905 Modification EZ-1 System Repiratory SensorsPro-Tech Services, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK040194 Compumedics Summit IPCompumedics USA, Ltd. · 2004
- Descendant · 2 generations on · 10 of its ownK043132 Universal XacttraceMedcare Flaga · 2004
- Descendant · 3 generations on · 7 of its ownK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009
- Descendant · 4 generations on · 3 of its ownK151940 Thora-3Di, Model T-01Pneumacare Limited · 2016
- Descendant · 5 generations on · 2 of its ownK242001 Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K040194Compumedics Summit IPCompumedics USA, Ltd. · 2004 · cites it directly13descendants
- K043132Universal XacttraceMedcare Flaga · 2004 · 2 generations on10descendants
- K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc. · 2009 · 3 generations on7descendants
- K151940Thora-3Di, Model T-01Pneumacare Limited · 2016 · 4 generations on3descendants
- K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V. · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013905 | Modification EZ-1 System Repiratory Sensors | Pro-Tech Services, Inc. | 2002 | — |
| +1 | K040194 | Compumedics Summit IP | Compumedics USA, Ltd. | 2004 | — |
| +2 | K043132 | Universal Xacttrace | Medcare Flaga | 2004 | — |
| +3 | K090273 | Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot… | Kai Sensors, Inc. | 2009 | — |
| +4 | K151940 | Thora-3Di, Model T-01 | Pneumacare Limited | 2016 | — |
| +5 | K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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 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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040194 | Compumedics Summit IP | 2004 | 13 |
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, K040194 (Compumedics USA, Ltd., 2004) has gone furthest, with 13 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/K013905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013905: Modification EZ-1 System Repiratory Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026