510(k) · Cleared
ClearedIV Administration Set with Hand Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Dec 5, 2014 as substantially equivalent to K062700 (B.Braun Medical, Inc., 2006) and 2 other predicates after a 247-day review. Its family tree reaches back 4 generations to 1990. 4 of the 34 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K904518 (1990). 27 ancestors in all, the oldest K780880 (1978). 6 later devices descend from it, 2 citing it directly. 4 of the 34 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK023189 Vista Basic with FM SystemB.Braun Medical, Inc. · 2003
- 1 generation backK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
- This deviceK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK153731 LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK213588 Q2 IV Administration SetsQuest Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK202618 IV Administration SetsB.Braun Medical, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK191362 LifeFlow Blood System410 Medical, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · cites it directly3descendants
- K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016 · cites it directly1descendant
- K213588Q2 IV Administration SetsQuest Medical, Inc. · 2022 · 2 generations on0descendants
- K202618IV Administration SetsB.Braun Medical, Inc. · 2021 · 2 generations on0descendants
- K191362LifeFlow Blood System410 Medical, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K023189 | Vista Basic with FM System | B.Braun Medical, Inc. | 2003 | — |
| −1 | K062700 | Infusomat Space Volumetric Infusion Pump System | B.Braun Medical, Inc. | 2006 | Class I |
| 0 (this device) | K140838 | IV Administration Set with Hand Pump | B.Braun Medical, Inc. | 2014 | — |
| +1 | K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017 | 19 |
| +1 | K153731 | LifeFlow Rapid Infusion Device (LifeFlow Device) | 410 Medical Innovation, LLC | 2016 | — |
| +2 | K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022 | — |
| +2 | K202618 | IV Administration Sets | B.Braun Medical, Inc. | 2021 | 1 |
| +2 | K191362 | LifeFlow Blood System | 410 Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 1 |
| 1997 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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.
4 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? (3)
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 |
|---|---|---|---|
| * | K062700 | Infusomat Space Volumetric Infusion Pump SystemSummary page 5…ION: Class II, Product Code FPA, 880.5440 PREDICATE DEVICES: Infusomat Space Volumetric Infusion Pump System, B. Braun Medical, Inc., K062700, Class II, FRN, 880.5725 Hospira Infusion Blood Sets, Hospira Inc., K101677, Class… | 2006 |
| * | K101677 | Hospira Infusion Blood SetsSummary page 5…sion Pump System, B. Braun Medical, Inc., K062700, Class II, FRN, 880.5725 Hospira Infusion Blood Sets, Hospira Inc., K101677, Class II, FPA, 880.5440 Blood Hand Pump Administration Set, Car… | 2010 |
| * | K050115 | Blood Hand Pump Administration SetSummary page 5…s II, FPA, 880.5440 Blood Hand Pump Administration Set, Cardinal Health, K050115, Class II, BRZ, 880.5440 DESCRIPTION: The IV Administration Sets with Hand Pump are single use, disposable, intravenous adminis… | 2005 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 16 of the 27 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K170595 (B.Braun Medical, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K062700.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 IV Administration Sets with Hand Pump are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. When the hand pump component is activated, the device is intended to deliver only crystalloid and colloid resuscitative fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140838: IV Administration Set with Hand Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140838
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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