510(k) Report

510(k) · Cleared

Cleared

Sidekick Infusion Kit

K990425510(k) TraditionalCleared Apr 23, 199971-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 Apr 23, 1999 as substantially equivalent to K984146 (I-Flow Corp., 1999) and 6 other predicates after a 71-day review. Its family tree reaches back 4 generations to 1990.

Decided
Apr 23, 1999
Review
71 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K896422 (1990). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1995: 1 other ancestor1993: 2 other ancestorsK896422 · Burron Ambulatory Drug Delivery System · Burron Medical, Inc. · 1990K980558 · Painbuster Infusion System · I-Flow Corp. · 1998K982946 · Painbuster Infusion Kit · I-Flow Corp. · 1998K984146 · Paragon Infusion · I-Flow Corp. · 1999199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K984146 · Paragon Infusion · I-Flow Corp. · 1999K982946 · Painbuster Infusion Kit · I-Flow Corp. · 1998K980558 · Painbuster Infusion System · I-Flow Corp. · 1998K896422 · Burron Ambulatory Drug Delivery System · Burron Medical, Inc. · 19900
  1. Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
  2. 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
  3. 2 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
  4. 1 generation backK984146 Paragon InfusionI-Flow Corp. · 1999
  5. This deviceK990425 Sidekick Infusion KitI-Flow Corp. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K896422Burron Ambulatory Drug Delivery SystemBurron Medical, Inc.1990—
−3K980558Painbuster Infusion SystemI-Flow Corp.1998—
−2K982946Painbuster Infusion KitI-Flow Corp.1998—
−1K984146Paragon InfusionI-Flow Corp.1999—
0 (this device)K990425Sidekick Infusion KitI-Flow Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199510
199810
FIG. 1 — Lineage of K990425, 1990–1999Source: 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), 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.

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
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What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K984146Paragon Infusion
Summary page 2
…ces that have been granted permission to market via premarket notification regulation). The SideKick Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control…
I-Flow Corp.1999—
*K923875Sidekick 50 Plus and Sidekick 100 Plus
Summary page 2
…t via premarket notification regulation). The SideKick Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Hom…
I-Flow Corp.19931
*K980558Painbuster Infusion System
Summary page 2
…SideKick Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outb…
I-Flow Corp.1998—
*K982946Painbuster Infusion Kit
Summary page 2
…Kit is substantially equivalent to the I-Flow Paragon Infusion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disp…
I-Flow Corp.1998—
*K896422Burron Ambulatory Drug Delivery System
Summary page 2
…usion Kit (K984146), the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disposable Syringe Infuser (K982256). 2.0 PHYSICAL SPECIFICAT…
Burron Medical, Inc.1990—
*K944692C-Series Homepump
Summary page 2
…Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disposable Syringe Infuser (K982256). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS Description of the…
Block Medical, Inc.1995—
*K982256Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump
Summary page 2
…K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692) and the McKinley Outbound Disposable Syringe Infuser (K982256). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS Description of the SideKick Infusion Kit 2.1 2.2 2.1.1 2.1.2 213 21.4 215…
Mckinley, Inc.1998—

Also cleared against K984146: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K984146.

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)—

What is it indicated for?

The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K984146

2 other devices cite the same predicate.

  • K043204Sgarlato Labs Painfree Pump and Pain Control Infusion PumpSgarlato Laboratories, Inc. · 2005
  • K020251Paragon Infusion SystemI-Flow Corp. · 2002

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/K990425 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990425: Sidekick Infusion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990425

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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