510(k) Report

510(k) · Cleared

Cleared

Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo

K020660510(k) SpecialCleared Mar 20, 200219-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. · MEB Pump, Infusion, Elastomeric

Cleared on Mar 20, 2002 as substantially equivalent to K932740 (Block Medical, Inc., 1993) and 5 other predicates after a 19-day review. Its family tree reaches back 5 generations to 1990.

Decided
Mar 20, 2002
Review
19 days
Class
Class II
Product code
MEB
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K896422 (1990). 19 ancestors in all, the oldest K890489 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 5 other ancestors1995: 2 other ancestors1993: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1990: 1 other ancestor1989: 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. · 1999K020251 · Paragon Infusion System · I-Flow Corp. · 20021985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 9 other ancestors K020251 · Paragon Infusion System · I-Flow Corp. · 2002K984146 · 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. · 1990−50
  1. Root · 5 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
  2. 4 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
  3. 3 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
  4. 2 generations backK984146 Paragon InfusionI-Flow Corp. · 1999
  5. 1 generation backK020251 Paragon Infusion SystemI-Flow Corp. · 2002
  6. This deviceK020660 Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One…I-Flow Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K896422Burron Ambulatory Drug Delivery SystemBurron Medical, Inc.1990—
−4K980558Painbuster Infusion SystemI-Flow Corp.1998—
−3K982946Painbuster Infusion KitI-Flow Corp.1998—
−2K984146Paragon InfusionI-Flow Corp.1999—
−1K020251Paragon Infusion SystemI-Flow Corp.2002—
0 (this device)K020660Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step KvoI-Flow Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199010
199320
199520
199610
199810
199950
FIG. 1 — Lineage of K020660, 1990–2002Source: 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 MEB? 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 MEB device

  1. #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 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? (6)

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
*K932740Homepump NSF
Summary page 1
…re Manager, Regulatory Affairs I-Flow Corporation I-Flow Variable Rate Elastomeric Pump Infusion Pump and Administration Set Pump, Infusion I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072) The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source wit…
Block Medical, Inc.19935
*K944692C-Series Homepump
Summary page 1
…er, Regulatory Affairs I-Flow Corporation I-Flow Variable Rate Elastomeric Pump Infusion Pump and Administration Set Pump, Infusion I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072) The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an inte…
Block Medical, Inc.1995—
*K984502Nerve Block Infusion Kit
Summary page 1
…atory Affairs I-Flow Corporation I-Flow Variable Rate Elastomeric Pump Infusion Pump and Administration Set Pump, Infusion I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072) The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated ad…
I-Flow Corp.1999—
*K991513Homepump C-Series and Homepump C-Series One-Step Kvo
Summary page 1
…airs I-Flow Corporation I-Flow Variable Rate Elastomeric Pump Infusion Pump and Administration Set Pump, Infusion I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072) The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administrat…
I-Flow Corp.19991
*K992072Bolus Accessory Set
Summary page 1
…Corporation I-Flow Variable Rate Elastomeric Pump Infusion Pump and Administration Set Pump, Infusion I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513 and K992072) The I-Flow Variable Rate Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. Th…
I-Flow Corp.1999—
*K020251Paragon Infusion System
Summary page 1
…pecial 510(k) proposes a new component that incorporates a variable flow rate mechanism. The Variable Flow Rate Component is identical to the one recently cleared under K020251. Conclusion: The |-Flow Variable Rate Elastomeric Pump is substantially equivalent to the existing |-Flow Elastomeric Pump and t…
I-Flow Corp.2002—

Also cleared against K932740: 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 12 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K932740.

How does its category compare?

All MEB devices

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

FDA decisions per year · MEB

2in 2024

2007: 52008: 22009: 12013: 12014: 12016: 12019: 12024: 22026 (partial year): 1
2007high 5 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEB

42in 2007

2007: 42 days median
2007high 42 (2007)2026

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

Recalls per year · MEB

17in 2018

2007: 12008: 32009: 482010: 22011: 8, 1 Class I2013: 2, 1 Class I2018: 17
2007high 48 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · MEB

1,408in 2025

2007: 1102008: 4442009: 7982010: 1,8272011: 2,2652012: 1,9762013: 1,9562014: 2,6952015: 2,9802016: 2,1472017: 1,6532018: 1,4732019: 9742020: 2,7322021: 1,8022022: 1,2882023: 1,2482024: 1,4242025: 1,408
2007high 2,980 (2015) · low 110 (2007)2025

MAUDE reports naming product code MEB, 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
20075421110
20082—3444
20091—48798
20100—21,827
20110—8 (1)2,265
20120—01,976
20131—2 (1)1,956
20141—02,695
20150—02,980
20161—02,147
20170—01,653
20180—171,473
20191—0974
20200—02,732
20210—01,802
20220—01,288
20230—01,248
20242—01,424
20250—01,408
20261—0—

What is it indicated for?

1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as…

Read the full statement (90 words)

1. The I-Flow Variable Rate Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.

2. The I-Flow Variable Rate Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.

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 K932740

2 other devices cite the same predicate.

  • K020862I-Flow Elastomeric PumpI-Flow Corp. · 20021 recall
  • K980558Painbuster Infusion SystemI-Flow Corp. · 1998

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 MEB

The MEB category page

  • K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
  • K240624InfuLifeFirst Medical Source, LLC · 2024
  • K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
  • K181360ON-Q* Pump with BolusHalyard Health · 2019
  • K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016

https://510kreport.com/device/K020660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020660: Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020660

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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