510(k) · Cleared
Recalled · 2005Algo 3I 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 Apr 9, 2003 as substantially equivalent to K013137 (Natus Medical, Inc., 2001) after a 26-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 9, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936039 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK936039 Algo-2 Newborn Hearing ScreenerNatus Medical, Inc. · 1995 · Recalled
- 1 generation backK013137 Algo 3 Newborn Hearing ScreenerNatus Medical, Inc. · 2001 · Recalled
- This deviceK030823 Algo 3I Newborn Hearing ScreenerNatus Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK211147 ALGO 7iPath Medical GmbH · 2021
Most influential descendants
Showing 1 of 1 · See all- K211147ALGO 7iPath Medical GmbH · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936039 | Algo-2 Newborn Hearing Screener | Natus Medical, Inc. | 1995 | 1 |
| −1 | K013137 | Algo 3 Newborn Hearing Screener | Natus Medical, Inc. | 2001 | 1 |
| 0 (this device) | K030823 | Algo 3I Newborn Hearing Screener | Natus Medical, Inc. | 2003 | — |
| +1 | K211147 | ALGO 7i | Path Medical GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K013137 | Algo 3 Newborn Hearing Screener | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211147 | ALGO 7i | 2021 | 0 |
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K211147 (Path Medical GmbH, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013137.
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 | — |
What is it indicated for?
The ALGO® 3i Newborn Hearing Screener is a portable, noninvasive instrument used to screen infants for hearing loss. The Screener uses AABR® technology. The screener is intended for babies between the ages of 34 weeks (gestational age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030823: Algo 3I Newborn Hearing Screener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030823
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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