510(k) · Cleared
ClearedPositube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paraproducts, Inc. · BTR Tube, Tracheal (W/Wo Connector)
Cleared on Mar 15, 2000 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Mar 15, 2000
- Review
- 68 days
- Class
- Class II
- Product code
- BTR
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK000045 PositubeParaproducts, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK092611 Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK143042 SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK193058 SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK041917 Plasiatek ActuatorPlasiatek, LLC · 2005
Class I recalls in this family
- K193058 SonarMed AirWave Airway Monitoring System3 generations on · 2020
Most influential descendants
Showing 4 of 4 · See all- K092611Sonarmed Airway Monitoring System, Model 0901Sonarmed, Inc. · 2010 · cites it directly2descendants
- K143042SonarMed AirWave, Airway Monitoring SystemSonarmed, Inc. · 2016 · 2 generations on1descendant
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 3 generations on0descendants
- K041917Plasiatek ActuatorPlasiatek, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000045 | Positube | Paraproducts, Inc. | 2000 | — |
| +1 | K092611 | Sonarmed Airway Monitoring System, Model 0901 | Sonarmed, Inc. | 2010 | — |
| +2 | K143042 | SonarMed AirWave, Airway Monitoring System | Sonarmed, Inc. | 2016 | 1 |
| +3 | K193058 | SonarMed AirWave Airway Monitoring System | Sonarmed, Inc. | 2020 | Class I |
| +1 | K041917 | Plasiatek Actuator | Plasiatek, LLC | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 BTR device
- #1 K251794 Tenax® Laser Resistant Endotracheal Tubescore 12.5 · 3 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K092611 (Sonarmed, Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BTR devicesBTR Tube, Tracheal (W/Wo Connector): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTR
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTR
258in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTR
3in 2022
Class I (20 since 2007) Class II/III not classified
Adverse event reports per year · BTR
1,799in 2025
MAUDE reports naming product code BTR, 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 | 1 | — | 2 | 136 |
| 2008 | 7 | 61 | 0 | 169 |
| 2009 | 7 | 135 | 21 | 155 |
| 2010 | 3 | 179 | 0 | 335 |
| 2011 | 2 | — | 0 | 422 |
| 2012 | 5 | 261 | 0 | 511 |
| 2013 | 1 | — | 0 | 807 |
| 2014 | 3 | 308 | 20 (19) | 985 |
| 2015 | 3 | 262 | 0 | 1,016 |
| 2016 | 1 | — | 1 | 836 |
| 2017 | 2 | — | 0 | 812 |
| 2018 | 5 | 242 | 0 | 977 |
| 2019 | 5 | 211 | 0 | 1,379 |
| 2020 | 3 | 246 | 1 (1) | 1,070 |
| 2021 | 1 | — | 2 | 1,329 |
| 2022 | 1 | — | 3 | 1,132 |
| 2023 | 1 | — | 0 | 1,330 |
| 2024 | 1 | — | 0 | 1,678 |
| 2025 | 7 | 258 | 0 | 1,799 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K000045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000045: Positube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000045
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026