510(k) · Cleared
ClearedCadwell Bolt Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cadwell Industries, Inc. · OLT Non-Normalizing Quantitative Electroencephalograph Software
Cleared on Nov 23, 2019 as substantially equivalent to K151929 (Persyst Development Corporation, 2015) and 2 other predicates after a 243-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Nov 23, 2019
- Review
- 243 days
- Class
- Class II
- Product code
- OLT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K875179 (1988). 52 ancestors in all, the oldest K791580 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 7 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 6 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 5 generations backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- 4 generations backK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- 3 generations backK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- 2 generations backK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- 1 generation backK173366 NicoletOneNatus Neurology Incorporated · 2018
- This deviceK190760 Cadwell Bolt SoftwareCadwell Industries, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −7 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −6 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −5 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| −4 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| −3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| −2 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| −1 | K173366 | NicoletOne | Natus Neurology Incorporated | 2018 | — |
| 0 (this device) | K190760 | Cadwell Bolt Software | Cadwell Industries, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
Planning a device in OLT? 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 OLT device
- #1 K253767 UB ERP Systemscore 14.9 · 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? (3)
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 |
|---|---|---|---|
| * | K151929 | Persyst 13 (P13) Eeg Review and Analysis SoftwareSummary page 5…ces (OHT5) Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A) Predicate Device: K151929 Persyst 13 EEG Review and Analysis Software; Primary Predicate… | 2015 |
| * | K173366 | NicoletOneSummary page 5…A) Predicate Device: K151929 Persyst 13 EEG Review and Analysis Software; Primary Predicate K173366 NicoletOne; Secondary predicate K161027 Cadwell Ampliscan; Secondary predicate Device Description:… | 2018 |
| * | K161027 | Cadwell AmpliScanSummary page 5…alysis Software; Primary Predicate K173366 NicoletOne; Secondary predicate K161027 Cadwell Ampliscan; Secondary predicate Device Description: Cadwell Bolt is a software-only device for use with EEG… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 10 of the 52 ancestors have a recall of any class.
- 4 other devices also cite its predicate K151929.
How does its category compare?
All OLT devicesOLT Non-Normalizing Quantitative Electroencephalograph Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, 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 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
What is it indicated for?
1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages. 2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following…
Read the full statement (247 words)
1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages.
2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers:
-Amplitude Integrated EEG (aEEG),
-Peak Envelope,
-Envelope Asymmetry,
-Spectrogram,
-Band Power,
-Power Ratio,
-Spectral Entropy,
-Burst Suppression Ratio,
-Inter-burst Interval, and
-Bursts-per-Minute.
These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis.
3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain.
4. Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190760: Cadwell Bolt Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190760
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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