510(k) · Cleared
Recalled · 2011Y-Type Blood Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KDC Instrument, Surgical, Disposable
Cleared on Jun 30, 1978 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 30, 1978
- Review
- 31 days
- Class
- Class I
- Product code
- KDC
- Recalls
- 4
- Predicates
- 0
31 later devices descend from it, 1 citing it directly. 5 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK780880 Y-Type Blood SetAbbott Laboratories · 1978
- Descendant · cites it directly · 30 of its ownK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 19 of its ownK113683 Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK141789 Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play…Hospira, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · 3 generations on · 5 of its ownK161469 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play…Hospira, Inc. · 2017 · Recalled (Class I)
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · cites it directly30descendants
- K113683Lifeshield Vision Infusion Set with Pre-Pierced ResealHospira, Inc. · 2012 · 2 generations on19descendants
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for…Hospira, Inc. · 2015 · 2 generations on9descendants
- K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
- K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. · 2017 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780880 | Y-Type Blood Set | Abbott Laboratories | 1978 | — |
| +1 | K101677 | Hospira Infusion Blood Sets | Hospira, Inc. | 2010 | Class I |
| +2 | K113683 | Lifeshield Vision Infusion Set with Pre-Pierced Reseal | Hospira, Inc. | 2012 | — |
| +2 | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0… | Hospira, Inc. | 2015 | Class I |
| +2 | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +3 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Hospira, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 1 |
| 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), 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.
- 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? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101677 | Hospira Infusion Blood Sets Class I | 2010 | 30 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2011 | Not classified | Z-2025-2011 | Other | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| Mar 28, 2011 | Not classified | Z-2026-2011 | Other | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| Mar 28, 2011 | Not classified | Z-2024-2011 | Other | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| Nov 24, 2009 | Not classified | Z-1392-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
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.
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 18 Class I recalls
- K141789Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion…Hospira, Inc. · 2015 · 2 generations on · ◆ 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 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K223607Plum Duo™ Infusion SystemIcu Medical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
What does this lineage say?
- Of its descendants, K101677 (Hospira, Inc., 2010) has gone furthest, with 30 descendants of its own.
How does its category compare?
All KDC devicesKDC Instrument, Surgical, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDC
FDA has decided no KDC device since 2007.
Median 510(k) review, days · KDC
Too few KDC 510(k)s in any year since 2007 to give a median.
Recalls per year · KDC
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDC
7in 2025
MAUDE reports naming product code KDC, 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 | 0 | — | 2 | 2 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 9 |
| 2011 | 0 | — | 4 | 6 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 538 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K780880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K780880: Y-Type Blood Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780880
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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