510(k) · Cleared
Recalled · Class II · 2026FilmArray NGDS Warrior Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Defense, LLC · PRD (no longer in FDA’s product-code list)
Cleared on Jun 22, 2017 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 22, 2017
- Review
- 90 days
- Product code
- PRD
- Recalls
- 3
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK170883 FilmArray NGDS Warrior PanelBiofire Defense, LLC · 2017
- Descendant · cites it directly · 2 of its ownK213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control…Biofire Defense, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK253653 Xpert Hemorrhagic FeverCepheid · 2026
- Descendant · cites it directly · 1 of its ownK252072 Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention · 2025
- Descendant · 3 generations on · 0 of its ownK261362 Xpert Hemorrhagic FeverCepheid · 2026
- Descendant · 2 generations on · 0 of its ownK260812 Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire…Biofire Defense, LLC · 2023 · cites it directly2descendants
- K253653Xpert Hemorrhagic FeverCepheid · 2026 · 2 generations on1descendant
- K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention · 2025 · cites it directly1descendant
- K261362Xpert Hemorrhagic FeverCepheid · 2026 · 3 generations on0descendants
- K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170883 | FilmArray NGDS Warrior Panel | Biofire Defense, LLC | 2017 | — |
| +1 | K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for… | Biofire Defense, LLC | 2023 | — |
| +2 | K253653 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| +1 | K252072 | Francisella tularensis Real-time PCR assay | Centers for Disease Control and Prevention | 2025 | — |
| +3 | K261362 | Xpert Hemorrhagic Fever | Cepheid | 2026 | — |
| +2 | K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 PRD? 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? (7)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2026 | Class II | Z-2877-2026 | Under Investigation by firm | Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test. |
| Jul 10, 2025 | Class II | Z-2609-2025 | Component design/selection | FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup. |
| Aug 20, 2019 | Class III | Z-1448-2020 | Labeling Change Control | The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K213362 (Biofire Defense, LLC, 2023) has gone furthest, with 2 descendants of its own.
https://510kreport.com/device/K170883 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170883: FilmArray NGDS Warrior Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170883
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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