510(k) Report

510(k) · Cleared

Recalled · 2010

Intravascular Administration Set

K891919510(k) TraditionalCleared May 5, 198939-day reviewClass II21 CFR 880.5570Recalls 75

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

Multi-Med, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on May 5, 1989 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it. It has been recalled 75 times.

Decided
May 5, 1989
Review
39 days
Class
Class II
Product code
FMI
Recalls
75
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2002: 3 descendants cleared2003: 1 descendant cleared2001: 1 descendant cleared2005: 2 descendants cleared2017: 5 descendants cleared2004: 4 descendants cleared2007: 11 descendants cleared2008: 7 descendants cleared2009: 3 descendants cleared2016: 1 descendant cleared2006: 1 descendant cleared2011: 5 descendants cleared2012: 3 descendants cleared2014: 3 descendants cleared2019: 2 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2021: 3 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2013: 6 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK891919 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 81 descendants. See all descendants

Descendants cleared per year

2000: 12001: 12002: 32003: 12004: 42005: 22006: 12007: 112008: 72009: 32010: 22011: 52012: 32013: 62014: 32015: 22016: 12017: 52019: 22020: 22021: 32023: 32024: 22025: 62026: 2
2000high 11 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 81 · 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)K891919Intravascular 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
200870
200930
201020
201150
201230
201360
201430
201520
201610
201750
201920
202020
202130
202330
202420
202560
202620
FIG. 1 — Lineage of K891919, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FMI? 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 FMI device

  1. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.200080

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 30, 2010Not classifiedZ-2508-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2536-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2516-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2558-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2535-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2518-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2549-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2527-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2515-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2563-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2568-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2550-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2578-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2539-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2561-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2552-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2560-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2546-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2538-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2540-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2520-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2511-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2564-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2575-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2533-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2573-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2559-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2569-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2548-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2544-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2513-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2543-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2577-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2551-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2510-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2571-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2522-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2526-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2529-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2562-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2567-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2534-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2528-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2542-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2509-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2574-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2532-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2537-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2521-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.
Aug 30, 2010Not classifiedZ-2576-2010Device DesignHuber needles may core and result in port leakage or emboli being flushed our of the port.

The 5 latest of 50 recalls; the web page lists all.

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 FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

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
  • K891072Intravascular Administration SetMulti-Med, Inc. · 1989
  • K890340Intravascular Administration SetMulti-Med, Inc. · 1989

Recent decisions in FMI

The FMI category page

  • K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety…Hh Global Technology, Inc. · 2026
  • K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K891919 · printed Nov 6, 2026

Cite this page

510(k) Report. “K891919: Intravascular Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891919

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026