510(k) Report

510(k) · Cleared

Cleared

Intravascular Administration Set

K891072510(k) TraditionalCleared Apr 21, 198951-day reviewClass II21 CFR 880.5440

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

Multi-Med, Inc. · FPA Set, Administration, Intravascular

Cleared on Apr 21, 1989 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 88 later devices descend from it.

Decided
Apr 21, 1989
Review
51 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
0

88 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2008: 8 descendants cleared2011: 6 descendants cleared2013: 7 descendants cleared2012: 6 descendants cleared2002: 3 descendants cleared2003: 1 descendant cleared2001: 1 descendant cleared2005: 2 descendants cleared2017: 5 descendants cleared2004: 4 descendants cleared2007: 11 descendants cleared2009: 3 descendants cleared2021: 4 descendants cleared2016: 1 descendant cleared2006: 1 descendant cleared2014: 3 descendants cleared2019: 2 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK891072 Intravascular Administration SetMulti-Med, Inc. · 1989
  2. Descendant · cites it directly · 80 of its ownK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 70 of its ownK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
  4. Descendant · 3 generations on · 68 of its ownK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
  5. Descendant · 3 generations on · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
  6. Descendant · 4 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2000: 12001: 12002: 32003: 12004: 42005: 22006: 12007: 112008: 82009: 32010: 22011: 62012: 62013: 72014: 32015: 22016: 12017: 52019: 22020: 22021: 42023: 32024: 22025: 62026: 2
2000high 11 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 88 · See all
  • K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · cites it directly80descendants
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · 2 generations on70descendants
  • K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004 · 3 generations on68descendants
  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · 3 generations on67descendants
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 4 generations on66descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891072Intravascular Administration SetMulti-Med, Inc.1989—
+1K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.20002
+2K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.20011
+3K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc.2004—
+3K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.20052
+4K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200230
200310
200440
200520
200610
2007110
200880
200930
201020
201160
201260
201370
201430
201520
201610
201750
201920
202020
202140
202330
202420
202560
202620
FIG. 1 — Lineage of K891072, 1989–2026Source: 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? (88)

See all 88

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.200080
K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc.20086

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K993848 (Millennium Medical Distribution, Inc., 2000) has gone furthest, with 80 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 Multi-Med, Inc.

7 FDA decisions under this applicant name. See the company

  • K890424Enteral Feeding ContainerMulti-Med, Inc. · 1989
  • K890396External Feeding Set for Pump UseMulti-Med, Inc. · 1989
  • K891176Injection Site Plug (Intravascular Administration)Multi-Med, Inc. · 1989
  • K891919Intravascular Administration SetMulti-Med, Inc. · 198975 recalls
  • K890340Intravascular Administration SetMulti-Med, Inc. · 1989

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The FPA category page

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https://510kreport.com/device/K891072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891072: Intravascular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891072

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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