510(k) · Cleared
Recalled · 2005Algo-2 Newborn Hearing Screener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · GWJ Stimulator, Auditory, Evoked Response
Cleared on Jan 5, 1995 after a 381-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 24 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 1995
- Review
- 381 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK936039 Algo-2 Newborn Hearing ScreenerNatus Medical, Inc. · 1995
- Descendant · cites it directly · 16 of its ownK993177 SABRESle Limited · 1999
- Descendant · 2 generations on · 14 of its ownK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- Descendant · 3 generations on · 9 of its ownK122067 Type 1077 AccuscreenGn Otometrics · 2012
- Descendant · 3 generations on · 5 of its ownK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · cites it directly · 5 of its ownK013137 Algo 3 Newborn Hearing ScreenerNatus Medical, Inc. · 2001 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K993177SABRESle Limited · 1999 · cites it directly16descendants
- K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002 · 2 generations on14descendants
- K122067Type 1077 AccuscreenGn Otometrics · 2012 · 3 generations on9descendants
- K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006 · 3 generations on5descendants
- K013137Algo 3 Newborn Hearing ScreenerNatus Medical, Inc. · 2001 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K936039 | Algo-2 Newborn Hearing Screener | Natus Medical, Inc. | 1995 | — |
| +1 | K993177 | SABRE | Sle Limited | 1999 | — |
| +2 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| +3 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| +3 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +1 | K013137 | Algo 3 Newborn Hearing Screener | Natus Medical, Inc. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWJ? 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 GWJ device
- #1 K242954 Integrity V500 (Integrity, Integrity with VEMP)score 10.0 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (24)
See all 243 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2005 | Not classified | Z-0985-05 | Other | Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993177 (Sle Limited, 1999) has gone furthest, with 16 descendants of its own.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GWJ
111in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWJ
1in 2025
MAUDE reports naming product code GWJ, 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 | 0 |
| 2008 | 4 | 64 | 1 | 0 |
| 2009 | 4 | 111 | 0 | 0 |
| 2010 | 1 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 43 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 1 | 5 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 0 | — | 1 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K936039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K936039: Algo-2 Newborn Hearing Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K936039
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026