510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Ivac (R) Unvented Vol. Infusion Set Model 52080

K882302510(k) TraditionalCleared Jul 12, 198840-day reviewClass II21 CFR 880.5440Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Y · FPA Set, Administration, Intravascular

Cleared on Jul 12, 1988 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled 2 times.

Decided
Jul 12, 1988
Review
40 days
Class
Class II
Product code
FPA
Recalls
2
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK882302 Ivac (R) Unvented Vol. Infusion Set Model 52080Y · 1988
  2. Descendant · cites it directly · 7 of its ownK050115 Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005
  3. Descendant · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
  4. Descendant · 3 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK153731 LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016
  6. Descendant · 4 generations on · 0 of its ownK213588 Q2 IV Administration SetsQuest Medical, Inc. · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12014: 12016: 12017: 12020: 22021: 12022: 1
2005high 2 (2020) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all
  • K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products · 2005 · cites it directly7descendants
  • K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
  • K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 3 generations on3descendants
  • K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC · 2016 · 3 generations on1descendant
  • K213588Q2 IV Administration SetsQuest Medical, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882302Ivac (R) Unvented Vol. Infusion Set Model 52080Y1988—
+1K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products2005—
+2K140838IV Administration Set with Hand PumpB.Braun Medical, Inc.2014—
+3K170595IV Administration SetsB.Braun Medical, Inc.201719
+3K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC2016—
+4K213588Q2 IV Administration SetsQuest Medical, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201410
201610
201710
202020
202110
202210
FIG. 1 — Lineage of K882302, 1988–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050115Blood Hand Pump Administration SetCardinal Health, Alaris Products20057

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 11, 2023Class IIZ-0350-2024Error in labelingAffected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Dec 20, 2012Class IIZ-0832-2013Nonconforming Material/ComponentCareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050115 (Cardinal Health, Alaris Products, 2005) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

More from Y

78 FDA decisions under this applicant name. See the company

  • K955846Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount ThermometerY · 1996
  • K960280Ivac Needle Free Valve Administration SetsY · 19967 recalls
  • K953225Ivac Ball Valce Admin. SetsY · 1995
  • K934095Ivac Vented Syringe Adapter Administration SetsY · 1994
  • K940897Ivac Needleless Infection Valve Administration SetY · 1994

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https://510kreport.com/device/K882302 · printed Nov 5, 2026

Cite this page

510(k) Report. “K882302: Ivac (R) Unvented Vol. Infusion Set Model 52080.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882302

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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