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)
FDA 510(k) clearance K242852 · decided 2025-06-13
Clearance details
- K-number
- K242852
- Device name
- 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)
- Applicant
- Inomed Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-09-20
- Decision date
- 2025-06-13
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Emmendingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Evala Nerve Stimulator (EPNR002) (K253536) | Epineuron Technologies, Inc. | 2026-02-27 |
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| Bioscope Neuromonitor Device (K233001) | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 |
| EARP Nerve Cuff Electrode (K241917) | Retropsoas Technologies, LLC | 2024-07-31 |
| Disposable Laryngeal Electrodes (K232888) | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 |
| NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320) | Medtronic Xomed, Inc. | 2023-10-26 |
| EARP Nerve Cuff Electrode (K230853) | Nvision Biomedical Technologies, Inc. | 2023-10-06 |
| NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580) | Medtronic Xomed, Inc. | 2023-08-30 |
| C2 Xplore (K223254) | Inomed Medizintechnik GmbH | 2023-01-27 |
| Mapping Suction Probe (K212164) | Inomed Medizintechnik GmbH | 2022-11-11 |
| NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246) | Medtronic Xomed, Inc. | 2022-03-21 |
| Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (K212355) | Checkpoint Surgical | 2021-08-26 |
Recalls involving this device
No recalls on record reference this clearance.