510(k) · Cleared
ClearedALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inomed Medizintechnik GmbH · ETN Stimulator, Nerve
Cleared on Jun 13, 2025 as substantially equivalent to K110989 (Neurovision Medical Products, Inc., 2011) after a 266-day review. Its family tree reaches back 6 generations to 1985. 2 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 13, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- ETN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K851426 (1985). 15 ancestors in all. No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 5 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 4 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
- 3 generations backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
- 2 generations backK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
- 1 generation backK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
- This deviceK242852 ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7…Inomed Medizintechnik GmbH · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −5 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −4 | K021174 | Ecom Endotrachial Cardiac Output Monitor | Imagyn Surgical | 2003 | — |
| −3 | K032491 | Ecom CV4 Endotracheal Cardiac Output Monitor | Imagyn Medical Technologies, Inc. | 2003 | — |
| −2 | K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube | Nuvasive, Inc. | 2010 | — |
| −1 | K110989 | Neurovision Ink Printed Endotracheal Tube Electrode | Neurovision Medical Products, Inc. | 2011 | 10 |
| 0 (this device) | K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845)… | Inomed Medizintechnik GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 1 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 1 |
| 2009 | 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.
2 devices in this family have 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 ETN device
- #1 K251672 NIM Essence™ EMG Endotracheal Tube…score 12.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K110989 | Neurovision Ink Printed Endotracheal Tube ElectrodeSummary page 5…R Codes: Substantially Predicate device 510(k) Predicate device Manufacturer / Equivalent Devices: number Model K110989 Neurovision Medical Products, Inc. / Neurovision Ink Printed… | 2011 |
| † | K091874 | Inomed Adhesive Laryngeal Electrodes, Models 530655, 530656 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 6.7 years on median.
- 5 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
- 2 other devices also cite its predicate K110989.
How does its category compare?
All ETN devicesETN Stimulator, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ETN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETN
98in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ETN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETN
1,145in 2025
MAUDE reports naming product code ETN, 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 | 2 | — | 0 | 5 |
| 2008 | 2 | — | 1 | 5 |
| 2009 | 5 | 115 | 0 | 22 |
| 2010 | 3 | 168 | 1 | 26 |
| 2011 | 9 | 115 | 0 | 55 |
| 2012 | 7 | 179 | 0 | 187 |
| 2013 | 1 | — | 0 | 270 |
| 2014 | 2 | — | 0 | 137 |
| 2015 | 1 | — | 0 | 202 |
| 2016 | 2 | — | 1 | 145 |
| 2017 | 0 | — | 0 | 117 |
| 2018 | 0 | — | 0 | 250 |
| 2019 | 0 | — | 2 | 314 |
| 2020 | 1 | — | 1 | 238 |
| 2021 | 1 | — | 1 | 197 |
| 2022 | 2 | — | 0 | 247 |
| 2023 | 5 | 98 | 1 | 390 |
| 2024 | 2 | — | 0 | 748 |
| 2025 | 1 | — | 0 | 1,145 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ALM Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative neuromonitoring by recording the EMG activity of the laryngeal musculature when connected to an appropriate neuromonitoring device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242852: ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242852
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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