510(k) Report

510(k) · Cleared

Cleared

Vivus 50 and Vivus 100 Personal Infuser

K915646510(k) TraditionalCleared Jun 15, 1992180-day reviewClass II21 CFR 880.5725

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

I-Flow Corp. · FRN Pump, Infusion

Cleared on Jun 15, 1992 after a 180-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 15, 1992
Review
180 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared2000: 1 descendant cleared1990200020102020
  1. This deviceK915646 Vivus 50 and Vivus 100 Personal InfuserI-Flow Corp. · 1992
  2. Descendant · cites it directly · 2 of its ownK962663 Solopak Sidekick Infusion Pump and Administation SetSolopak Medical Products, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK990889 Autodose Infusion SystemTandem Medical, Inc. · 1999
  4. Descendant · 2 generations on · 0 of its ownK993832 Autodose Infusion System, Model AD4120, BE4210, S12050,100,200…Tandem Medical, Inc. · 2000

Most influential descendants

Showing 3 of 3 · See all
  • K962663Solopak Sidekick Infusion Pump and Administation SetSolopak Medical Products, Inc. · 1996 · cites it directly2descendants
  • K990889Autodose Infusion SystemTandem Medical, Inc. · 1999 · cites it directly1descendant
  • K993832Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10Tandem Medical, Inc. · 2000 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915646Vivus 50 and Vivus 100 Personal InfuserI-Flow Corp.1992—
+1K962663Solopak Sidekick Infusion Pump and Administation SetSolopak Medical Products, Inc.1996—
+1K990889Autodose Infusion SystemTandem Medical, Inc.1999—
+2K993832Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10Tandem Medical, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
FIG. 1 — Lineage of K915646, 1992–2000Source: 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 FRN? 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 FRN device

  1. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K962663Solopak Sidekick Infusion Pump and Administation SetSolopak Medical Products, Inc.19962
K990889Autodose Infusion SystemTandem Medical, Inc.19991

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, K962663 (Solopak Medical Products, Inc., 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

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

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

More from I-Flow Corp.

41 FDA decisions under this applicant name. See the company

  • K063530ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, EasypumpI-Flow Corp. · 20073 recalls
  • K063234ON-Q IntroducersI-Flow Corp. · 2006
  • K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005
  • K052117I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)I-Flow Corp. · 20053 recalls
  • K043456Modification to Soaker CatheterI-Flow Corp. · 2005

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K915646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915646: Vivus 50 and Vivus 100 Personal Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915646

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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