510(k) · Cleared
Recalled · Class II · 2021Steripath Gen2 Blood Collection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnolia Medical Technologies, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Feb 28, 2020 as substantially equivalent to K030573 (Bd Vacutainer Systems Preanalyical Solutions, 2003) after a 193-day review. Its family tree reaches back 5 generations to 1997. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 28, 2020
- Review
- 193 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970259 (1997). 8 ancestors in all, the oldest K921636 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 4 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 3 generations backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- 2 generations backK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- 1 generation backK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
- This deviceK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK200661 Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK231282 LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK220677 Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222299 Steripath Micro Blood Collection SystemMagnolia Medical Technologies · 2022
- Descendant · cites it directly · 0 of its ownK201237 Velano Vascular Blood Collection AdapterVelano Vascular · 2022
Most influential descendants
Showing 5 of 5 · See all- K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · cites it directly2descendants
- K231282LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC · 2024 · cites it directly0descendants
- K220677Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc. · 2023 · 2 generations on0descendants
- K222299Steripath Micro Blood Collection SystemMagnolia Medical Technologies · 2022 · 2 generations on0descendants
- K201237Velano Vascular Blood Collection AdapterVelano Vascular · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −4 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −3 | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | 7 |
| −2 | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | Becton, Dickinson & CO | 2002 | — |
| −1 | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | 5 |
| 0 (this device) | K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | — |
| +1 | K200661 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | — |
| +1 | K231282 | LifeOutcomes C-Quest™ Blood Culture Sampling Device | Lifeoutcomes, LLC | 2024 | — |
| +2 | K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | Kurin, Inc. | 2023 | — |
| +2 | K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies | 2022 | — |
| +1 | K201237 | Velano Vascular Blood Collection Adapter | Velano Vascular | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Summary page 4…Number: 862.1675 Regulatory Class: Class II Product Code: JKA and FPA Predicate Device: BD Vacutainer® Push Button Blood Collection Set (K030573) Device Description: The Steripath® Gen2 Blood Collection System diverts and sequesters the initia… | 2003 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Nov 2, 2021 | Class II | Z-0318-2022 | Process control | Due to an uptick of complaints associated with premature needle retraction of blood collection system. |
| Aug 2, 2021 | Class II | Z-2393-2021 | Labeling Change Control | Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K200661 (Magnolia Medical Technologies, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K030573.
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. 2020, 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 Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing. The Steripath® Gen2 Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test 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…
Read the full statement (109 words)
The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Gen2 Blood Collection System is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test 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.
Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192247: Steripath Gen2 Blood Collection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192247
Report an extraction error
Are you the manufacturer?
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