510(k) · Cleared
ClearedCadwell Sierra Summit, Cadwell Sierra Ascent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Industries, Inc. · IKN Electromyograph, Diagnostic
Cleared on Mar 1, 2017 as substantially equivalent to K112052 (Carefusion 209, Inc., 2012) after a 188-day review. Its family tree reaches back 4 generations to 1993. 12 later devices descend from it.
- Decided
- Mar 1, 2017
- Review
- 188 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922488 (1993). 14 ancestors in all, the oldest K874685 (1988). 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK922488 Phasis ElectromyographBiosound, Inc. · 1993
- 3 generations backK073415 Nemus System; Nemus PC PeripheralEb Neuro S.P.A. · 2008
- 2 generations backK102610 Focus Emg DeviceTeleemg, LLC USA · 2011
- 1 generation backK112052 Carefusion Nicolet EdxCarefusion 209, Inc. · 2012
- This deviceK162383 Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc. · 2017
- Descendant · cites it directly · 9 of its ownK182542 The EPAD 2 SystemSafeop Surgical, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK213849 SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK234092 SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK182617 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK191723 ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019 · cites it directly9descendants
- K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc. · 2022 · 2 generations on4descendants
- K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc. · 2024 · 3 generations on3descendants
- K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 2 generations on3descendants
- K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922488 | Phasis Electromyograph | Biosound, Inc. | 1993 | — |
| −3 | K073415 | Nemus System; Nemus PC Peripheral | Eb Neuro S.P.A. | 2008 | — |
| −2 | K102610 | Focus Emg Device | Teleemg, LLC USA | 2011 | — |
| −1 | K112052 | Carefusion Nicolet Edx | Carefusion 209, Inc. | 2012 | — |
| 0 (this device) | K162383 | Cadwell Sierra Summit, Cadwell Sierra Ascent | Cadwell Industries, Inc. | 2017 | — |
| +1 | K182542 | The EPAD 2 System | Safeop Surgical, Inc. | 2019 | — |
| +2 | K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024 | — |
| +2 | K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
| +3 | K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 IKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K112052 | Carefusion Nicolet EdxSummary page 6…® 510(k) Summary 3. Predicate Devices: 510(k) Number Device Name Primary Predicate K112052 Carefusion Nicolet EDX with Viking Software Reference Predicates K971214 Cadwell Kilowin (Easy II… | 2012 |
| † | K971214 | Kilowin | 1998 |
| † | K113184 | Logicscan 64 Logicscan 128 | 2012 |
| † | K070907 | Interson Usb Ultrasound Probe System | 2007 |
What descends from it? (12)
See all 122 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 24 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K182542 (Safeop Surgical, Inc., 2019) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K112052.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.…
Read the full statement (282 words)
Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities.
Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient’s condition to the user.
Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.
The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.
Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient’s condition to the user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162383
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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