510(k) · Cleared
ClearedNeuro Assessment System NAS-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Headsense Medical, Inc. · QBE Cranial Sound Monitor
Cleared on Mar 8, 2018 as substantially equivalent to K083903 (3M Company, 2009) after a 167-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Mar 8, 2018
- Review
- 167 days
- Class
- Class II
- Product code
- QBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771653 (1977). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771653 Electronic Stethoscope3M Company · 1977
- 4 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 3 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 2 generations backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- 1 generation backK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- This deviceK172892 Neuro Assessment System NAS-1000Headsense Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −4 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −3 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −2 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| −1 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| 0 (this device) | K172892 | Neuro Assessment System NAS-1000 | Headsense Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 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 QBE? 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 |
|---|---|---|---|
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 5…CE(S) [807.92(a)(3)] The predicate device to support substantial equivalence of the NAS-1000 System is the 3M™ Littmann® Electronic Stethoscope, Model 3200 cleared under K083903. DEVICE DESCRIPTION [807.92(a)(4)] The NAS-1000 System is a non-invasive, non-energy emitting device indicated for monitoring an… | 2009 |
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 41 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 7 ancestors has a recall.
- 16 other devices also cite its predicate K083903.
How does its category compare?
All QBE devicesQBE Cranial Sound Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBE
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QBE
Too few QBE 510(k)s in any year since 2007 to give a median.
Recalls per year · QBE
No recall names QBE since 2007.
Adverse event reports per year · QBE
No MAUDE report names QBE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NAS-1000 System is a medical acoustic system intended as an adjunct to standard clinical practice for use in non-invasively monitoring, detecting, recording and displaying acoustic signals in the brain. It is used for any subject undergoing a physical examination and intended only for medical assessment purposes in a clinic or hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172892: Neuro Assessment System NAS-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172892
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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