510(k) · Cleared
ClearedALGO Pro Newborn Hearing Screener (ALGO Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · GWJ Stimulator, Auditory, Evoked Response
Cleared on Mar 8, 2024 as substantially equivalent to K073665 (Natus Medical, Inc., 2008) after a 115-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 8, 2024
- Review
- 115 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936039 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK936039 Algo-2 Newborn Hearing ScreenerNatus Medical, Inc. · 1995 · Recalled
- 2 generations backK013137 Algo 3 Newborn Hearing ScreenerNatus Medical, Inc. · 2001 · Recalled
- 1 generation backK073665 Algo 5 Newborn Hearing ScreenerNatus Medical, Inc. · 2008
- This deviceK233649 ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936039 | Algo-2 Newborn Hearing Screener | Natus Medical, Inc. | 1995 | 1 |
| −2 | K013137 | Algo 3 Newborn Hearing Screener | Natus Medical, Inc. | 2001 | 1 |
| −1 | K073665 | Algo 5 Newborn Hearing Screener | Natus Medical, Inc. | 2008 | — |
| 0 (this device) | K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024 | — |
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 |
|---|---|---|---|
| * | K073665 | Algo 5 Newborn Hearing ScreenerSummary page 4…Regulation Number: 21 CFR 882.1900 Classification Name: Stimulator, Auditory, Evoked Response Product code: GWJ Device Class: II Predicate Device: ALGO 5 510(k) number: K073665 Page 1 of 11 ALGO Pro 510k DEVICE DESCRIPTION:… | 2008 |
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 29 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All GWJ devicesGWJ Stimulator, Auditory, Evoked Response: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) technology for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. The screener is intended for babies between the ages of 34 weeks (gestation age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and…
Read the full statement (157 words)
The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) technology for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. The screener is intended for babies between the ages of 34 weeks (gestation 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 as stated in the FDA summary.
https://510kreport.com/device/K233649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233649: ALGO Pro Newborn Hearing Screener (ALGO Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233649
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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