510(k) · Cleared
ClearedSABRE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sle Limited · GWJ Stimulator, Auditory, Evoked Response
Cleared on Nov 16, 1999 as substantially equivalent to K936039 (Natus Medical, Inc., 1995) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1993. 16 later devices descend from it.
- Decided
- Nov 16, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- GWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K925648 (1993). 3 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925648 Smart-Screener (Auditory)Intelligent Hearing Systems · 1993
- This deviceK993177 SABRESle Limited · 1999
- Descendant · cites it directly · 14 of its ownK013977 Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002
- Descendant · 2 generations on · 9 of its ownK122067 Type 1077 AccuscreenGn Otometrics · 2012
- Descendant · 2 generations on · 5 of its ownK061744 Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006
- Descendant · 3 generations on · 4 of its ownK133012 SentieroPath Medical GmbH · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK132957 Madsen Accuscreen Type 1077Gn Otometrics · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc. · 2002 · cites it directly14descendants
- K122067Type 1077 AccuscreenGn Otometrics · 2012 · 2 generations on9descendants
- K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp. · 2006 · 2 generations on5descendants
- K133012SentieroPath Medical GmbH · 2014 · 3 generations on4descendants
- K132957Madsen Accuscreen Type 1077Gn Otometrics · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925648 | Smart-Screener (Auditory) | Intelligent Hearing Systems | 1993 | — |
| 0 (this device) | K993177 | SABRE | Sle Limited | 1999 | — |
| +1 | K013977 | Echo-Screen T, TA, TD, Tda, TC | Fischer-Zoth Audiologic Systems, Inc. | 2002 | — |
| +2 | K122067 | Type 1077 Accuscreen | Gn Otometrics | 2012 | — |
| +2 | K061744 | Cochlea-Scan / Cochlea-Scan Plus | Bio-Logic Systems Corp. | 2006 | — |
| +3 | K133012 | Sentiero | Path Medical GmbH | 2014 | 4 |
| +2 | K132957 | Madsen Accuscreen Type 1077 | Gn Otometrics | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 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? (3)
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 Screener Our OCR of the scanned summary read K936093, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Algo-2 Newborn Hearing Screener”. | 1995 |
| * | K952080 | Clarity System IISummary page 1…n Number: 21 CFR 882.1900/Procode: 84 GWJ Subslantial Equivalence: Nalus Medical, Inc. Algo-2 Newborn Hearing Screener (K936093), Sonamed Corporation Clarity Systam II (K952080), Intelligent Hearing Systems SmartScreener (K925648), and others. Device Description: The SABRE ABR Screcncer is an evoked poat… | 1995 |
| * | K925648 | Smart-Screener (Auditory)Summary page 1…l Equivalence: Nalus Medical, Inc. Algo-2 Newborn Hearing Screener (K936093), Sonamed Corporation Clarity Systam II (K952080), Intelligent Hearing Systems SmartScreener (K925648), and others. Device Description: The SABRE ABR Screcncer is an evoked poatenttal device to he utRed in the evalnation nf hearin… | 1993 |
What descends from it? (16)
See all 162 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)
No FDA recall names this device.
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 SABRE Auditory Brainstem Response Screener ig a device that produces a sound stimulus for use in evoked responsc mcasurcments. It is intended to be used by trained protessiocnals in ‘the evaluation of hearing function.
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/K993177 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993177: SABRE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993177
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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