510(k) · Cleared
Recalled · Class I · 2013Hospira Infusion Blood Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 11, 2010 as substantially equivalent to K063239 (Hospira, Inc., 2006) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 2003. 5 of the 35 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it. It has been recalled 13 times, including 8 Class I recalls.
- Decided
- Aug 11, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 13 (8 Class I)
- Predicates
- 3
Its longest line of descent runs back 2 generations to K030467 (2003). 4 ancestors in all, the oldest K780880 (1978). 30 later devices descend from it, 8 citing it directly. 5 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 1 generation backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- This deviceK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010
- Descendant · cites it directly · 19 of its ownK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK142974 Extension SetsHospira, Inc. · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012 · cites it directly19descendants
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · cites it directly9descendants
- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · cites it directly6descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on5descendants
- K142974Extension SetsHospira, Inc. · 2015 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −1 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| 0 (this device) | K101677 | Hospira Infusion Blood Sets | Hospira, Inc. | 2010 | — |
| +1 | K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | Hospira, Inc. | 2012 | — |
| +1 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +1 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +2 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
| +1 | K142974 | Extension Sets | Hospira, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 1 |
| 2016 | 4 | 0 |
| 2017 | 3 | 1 |
| 2019 | 1 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 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.
5 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 &…Summary page 1…[21 Claimed CFR Lifeshield Latex-Free Veniloop Connector with Prepierced Injection 807.92(a)(3)] Site, Non-DEHP (K063239) Lifeshield Latex-Free Plum Non-Vented Blood set (K030002) HEMA Y… | 2006 |
| * | K030002 | Lifeshield Primary IV Set Conv. Pin. Clave; LF LC 5000 Plumset-Dual W/Conv Pin & Cap…Summary page 1…ector with Prepierced Injection 807.92(a)(3)] Site, Non-DEHP (K063239) Lifeshield Latex-Free Plum Non-Vented Blood set (K030002) HEMA Y-Type Transfusion Blood Filter Pump Set 100 Inch-SL with P… | 2003 |
| * | K780880 | Y-Type Blood SetSummary page 1…(K030002) HEMA Y-Type Transfusion Blood Filter Pump Set 100 Inch-SL with Prepierced Reseals (Latex-Free) (K780880) Reason for, 510(k) ~ To offer a non-DEHP PVC alternative Infusion set with a manual submission b… | 1978 |
| * | — | Hospira Administration Blood Sets with Manual Blood Pump Named without a submission number |
What descends from it? (30)
See all 308 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | 2012 | 19 |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… Class I | 2015 | 9 |
| K140838 | IV Administration Set with Hand Pump | 2014 | 6 |
| K142974 | Extension Sets | 2015 | 4 |
| K142367 | Hospira Primary Sets | 2014 | 4 |
| K142433 | Hospira Extension Set | 2014 | 3 |
| K143087 | Hospira Blood Set | 2015 | 2 |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | 2015 | 1 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2013 | Class II | Z-1126-2014 | Process design | Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. |
| Sep 9, 2013 | Class II | Z-2060-2016 | Device Design | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. |
| Apr 1, 2013 | Class I | Z-1850-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1853-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1854-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1857-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1852-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1858-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1851-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Apr 1, 2013 | Class I | Z-1855-2013 | Device Design | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. |
| Jul 13, 2012 | Class II | Z-2075-2012 | Employee error | The float valve in the burette sticks to the burette wall and does not open or close properly. |
| Jan 12, 2012 | Not classified | Z-0817-2012 | Component design/selection | Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container. |
| Nov 10, 2011 | Not classified | Z-0292-2012 | Employee error | The float valve in the burette sticks to the burette wall and does not open or close properly. |
The 5 latest of 13 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K113683 (Hospira, Inc., 2012) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K063239.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Hospira Administration sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101677 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101677: Hospira Infusion Blood Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101677
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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