510(k) · Cleared
ClearedStaphaurex ZL30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellcome Diagnostics · GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.
Cleared on May 22, 1985 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 22, 1985
- Review
- 19 days
- Class
- Class I
- Product code
- GTN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK851949 Staphaurex ZL30Wellcome Diagnostics · 1985
- Descendant · cites it directly · 9 of its ownK071026 BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007
- Descendant · cites it directly · 3 of its ownK082140 Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK101879 Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK130894 Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I…Cepheid · 2013
- Descendant · cites it directly · 1 of its ownK102342 Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc) · 2007 · cites it directly9descendants
- K082140Xpert Mrsa/SA Blood Culture AssayCepheid · 2008 · cites it directly3descendants
- K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid · 2010 · 2 generations on2descendants
- K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid · 2013 · 2 generations on1descendant
- K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851949 | Staphaurex ZL30 | Wellcome Diagnostics | 1985 | — |
| +1 | K071026 | BD Geneohm Staphsr Assay | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007 | — |
| +1 | K082140 | Xpert Mrsa/SA Blood Culture Assay | Cepheid | 2008 | 2 |
| +2 | K101879 | Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 | Cepheid | 2010 | 1 |
| +2 | K130894 | Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV… | Cepheid | 2013 | — |
| +1 | K102342 | Keypath (TM) Mrsa/Mssa Blood Culture Test- BT | Microphage, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 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 GTN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 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?
- Of its descendants, K071026 (Bd Diagnostics (Geneohm Sciences Canada, Inc), 2007) has gone furthest, with 9 descendants of its own.
How does its category compare?
All GTN devicesGTN Antisera, Fluorescent, All Types, Staphylococcus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GTN
FDA has decided no GTN device since 2007.
Median 510(k) review, days · GTN
Too few GTN 510(k)s in any year since 2007 to give a median.
Recalls per year · GTN
No recall names GTN since 2007.
Adverse event reports per year · GTN
1in 2021
MAUDE reports naming product code GTN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K851949 · printed Nov 5, 2026
Cite this page
510(k) Report. “K851949: Staphaurex ZL30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851949
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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