510(k) · Cleared
ClearedLifeOutcomes C-Quest™ Blood Culture Sampling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifeoutcomes, LLC · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jan 26, 2024 as substantially equivalent to K192247 (Magnolia Medical Technologies, Inc., 2020) after a 268-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jan 26, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970259 (1997). 9 ancestors in all, the oldest K921636 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 5 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 4 generations backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- 3 generations backK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- 2 generations backK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
- 1 generation backK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · Recalled
- This deviceK231282 LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −5 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −4 | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | 7 |
| −3 | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | Becton, Dickinson & CO | 2002 | — |
| −2 | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | 5 |
| −1 | K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | 2 |
| 0 (this device) | K231282 | LifeOutcomes C-Quest™ Blood Culture Sampling Device | Lifeoutcomes, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K192247 | Steripath Gen2 Blood Collection SystemSummary page 4…ood Specimen Collection Device Regulation 21 CFR §862.1675 Number: Product Code: JKA Predicate Device: Steripath® Gen2 Blood Collection System (K192247) Device Description: The LifeOutcomes LLC (LO) C-Quest™ Blood Culture Sampling Device (C-Quest) is a blo… | 2020 |
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 27 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192247.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The LifeOutcomes C-Quest Blood Culture Sampling Device (C-Quest) is a device intended to collect a patient blood sample and sequester the first portion of the sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion. It is used in conjunction with either a scalp vein set for venipuncture or access to an existing patient IV using an extension set. C-Quest may be used with a blood culture tube or a standard blood collection syringe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231282: LifeOutcomes C-Quest™ Blood Culture Sampling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231282
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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