510(k) · Cleared
ClearedSteripath Micro Blood Collection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnolia Medical Technologies, Inc. · FPA Set, Administration, Intravascular
Cleared on Oct 8, 2020 as substantially equivalent to K192247 (Magnolia Medical Technologies, Inc., 2020) after a 210-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Oct 8, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970259 (1997). 9 ancestors in all, the oldest K921636 (1992). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK200661 Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220677 Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222299 Steripath Micro Blood Collection SystemMagnolia Medical Technologies · 2022
Most influential descendants
Showing 2 of 2 · See allView 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) | K200661 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | — |
| +1 | K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | Kurin, Inc. | 2023 | — |
| +1 | K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 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…collection set Regulation Name: Blood Specimen Collection Device Regulation Number: 862.1675 Regulatory Class: Class II Product Code: JKA and FPA Predicate Device: K192247-Steripath® Gen2 Blood Collection System K192247, Reg 862.1675, Product codes JKA & FPA, Class II Device Description: T… | 2020 |
| † | K964435 | Primary IV Set | 1997 |
| † | K980987 | Becton Dickinson Syringe | 1998 |
| † | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342… | 2003 |
| † | K991088 | Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok… | 1999 |
| † | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing | 2008 |
What descends from it? (2)
2 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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K220677 (Kurin, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K192247.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Steripath® Micro Blood Collection System is a system to draw blood for in vitro diagnostic testing.
The Steripath® Micro 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®).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200661: Steripath Micro Blood Collection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200661
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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