510(k) · Cleared
Recalled · 2009Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FPK Tubing, Fluid Delivery
Cleared on Dec 11, 2006 as substantially equivalent to K030467 (Iv Medical, Inc., 2003) after a 46-day review. Its family tree reaches back 1 generation to 2003. 5 of the 58 devices in its family, counting itself, have a Class I recall. 56 later devices descend from it. It has been recalled 7 times.
- Decided
- Dec 11, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- FPK
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030467 (2003). 56 later devices descend from it, 2 citing it directly. 5 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- This deviceK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006
- Descendant · cites it directly · 30 of its ownK101677 Hospira Infusion Blood SetsHospira, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 24 of its ownK080579 Effectiv (TM) CapHospira, Inc. · 2008
- Descendant · 2 generations on · 23 of its ownK083508 SwabcapExcelsior Medical Corp. · 2009
- 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)
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 56 · See all- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · cites it directly30descendants
- K080579Effectiv (TM) CapHospira, Inc. · 2008 · cites it directly24descendants
- K083508SwabcapExcelsior Medical Corp. · 2009 · 2 generations on23descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| 0 (this device) | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | — |
| +1 | K101677 | Hospira Infusion Blood Sets | Hospira, Inc. | 2010 | Class I |
| +1 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| +2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 1 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 0 |
| 2017 | 3 | 1 |
| 2019 | 1 | 1 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 1 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension SetSummary page 2…TM Dial-A-Flo® set family and GraviTech TM Flow Controller Primary Set / GraviTech flow Controller Extension Set (cleared under K030467 to IVMedical Inc.) The claim for substantial equivalence is supported by the information provided in the 510(k) submission. ===… | 2003 |
| * | — | LifeShield® Latex-Free Regulator I.V. Dial-A-Flo® set family Named without a submission number |
What descends from it? (56)
See all 562 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2009 | Not classified | Z-1330-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1390-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1333-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1336-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1331-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1391-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
| Nov 24, 2009 | Not classified | Z-1327-2010 | Component design/selection | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. |
The 5 latest of 7 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.
- 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?
- Its one ancestor has no recall.
- Of its descendants, K101677 (Hospira, Inc., 2010) has gone furthest, with 30 descendants of its own.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | 1 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LifeShield® Latex-Free GraviTechTM Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTechTM Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063239: Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063239
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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