510(k) · Cleared
Recalled · 2005Algo 3 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 Oct 16, 2001 as substantially equivalent to K936039 (Natus Medical, Inc., 1995) after a 27-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 16, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936039 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK936039 Algo-2 Newborn Hearing ScreenerNatus Medical, Inc. · 1995 · Recalled
- This deviceK013137 Algo 3 Newborn Hearing ScreenerNatus Medical, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK073665 Algo 5 Newborn Hearing ScreenerNatus Medical, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK030823 Algo 3I Newborn Hearing ScreenerNatus Medical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK233649 ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2024
- Descendant · 2 generations on · 0 of its ownK211147 ALGO 7iPath Medical GmbH · 2021
- Descendant · cites it directly · 0 of its ownK111555 Circumaural Adhesive ReplacementR & D Medical Products, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K073665Algo 5 Newborn Hearing ScreenerNatus Medical, Inc. · 2008 · cites it directly1descendant
- K030823Algo 3I Newborn Hearing ScreenerNatus Medical, Inc. · 2003 · cites it directly1descendant
- K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2024 · 2 generations on0descendants
- K211147ALGO 7iPath Medical GmbH · 2021 · 2 generations on0descendants
- K111555Circumaural Adhesive ReplacementR & D Medical Products, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936039 | Algo-2 Newborn Hearing Screener | Natus Medical, Inc. | 1995 | 1 |
| 0 (this device) | K013137 | Algo 3 Newborn Hearing Screener | Natus Medical, Inc. | 2001 | — |
| +1 | K073665 | Algo 5 Newborn Hearing Screener | Natus Medical, Inc. | 2008 | — |
| +1 | K030823 | Algo 3I Newborn Hearing Screener | Natus Medical, Inc. | 2003 | 1 |
| +2 | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024 | — |
| +2 | K211147 | ALGO 7i | Path Medical GmbH | 2021 | — |
| +1 | K111555 | Circumaural Adhesive Replacement | R & D Medical Products, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K936039 | Algo-2 Newborn Hearing ScreenerSummary page 1…ator, Auditory Evoked Response Common/usual name Hearing Screener Proprietary name ALGO® 3 Newborn Hearing Screener C. Predicate Device: ALGO-2 Newborn Hearing Screener, K 936039 D. Device Description: Like the predicate device, the ALGO 3 detects the auditory brainstem response (ABR) to 2 series of stimu… | 1995 |
What descends from it? (5)
3 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?
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® 3 Newborn Hearing Screener is a mobile, 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. The screener is simple to operate. It does not require special…
Read the full statement (140 words)
The ALGO® 3 Newborn Hearing Screener is a mobile, 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.
The screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health and about to be discharged from the hospital. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother’s bedside, audiology suite, outpatient clinic, or doctor’s office.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013137: Algo 3 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/K013137
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026