510(k) · Cleared

Recalled · 2002

I-Flow Elastomeric Pump

K020862510(k) SpecialCleared Mar 26, 20028-day reviewClass II21 CFR 880.5725Recalls 1

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 26, 2002 as substantially equivalent to K932740 (Block Medical, Inc., 1993) and 4 other predicates after an 8-day review. Its family tree reaches back 4 generations to 1990. 2 of the 33 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it. It has been recalled once.

Decided: Mar 26, 2002
Review: 8 days
Class: Class II
Product code: MEB
Recalls: 1
Predicates: 5

Its longest line of descent runs back 4 generations to K896422 (1990). 13 ancestors in all, the oldest K884505 (1989). 19 later devices descend from it, 2 citing it directly. 2 of the 33 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
2 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
1 generation backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
This deviceK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002
Descendant · cites it directly · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
Descendant · 2 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
Descendant · 2 generations on · 8 of its ownK032642 Beeline SystemMckinley, Inc. · 2003
Descendant · 3 generations on · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004
Descendant · 4 generations on · 6 of its ownK050770 Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2002high 4 (2005) · low 0 (2007)2026

Class I recalls in this family

K023318 I-Flow Elastomeric Pump with Boluscites it directly · 2002
K081905 Accuflow and Accuflux Elastomeric Infusion Pump5 generations on · 2008

Most influential descendants

Showing 5 of 19 · See all

K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · cites it directly17descendants
K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 2 generations on15descendants
K032642Beeline SystemMckinley, Inc. · 2003 · 2 generations on8descendants
K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · 3 generations on7descendants
K050770Modification to Accufuser, Accufuser Plus Standard Procedure KitMckinley Medical, LLC · 2005 · 4 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K896422	Burron Ambulatory Drug Delivery System	Burron Medical, Inc.	1990	—
−3	K980558	Painbuster Infusion System	I-Flow Corp.	1998	—
−2	K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	—
−1	K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	—
0 (this device)	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	—
+1	K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	—
+2	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	2003	—
+2	K032642	Beeline System	Mckinley, Inc.	2003	—
+3	K042228	Beeline Motiv, Propolis, Pca	Mckinley, Inc.	2004	—
+4	K050770	Modification to Accufuser, Accufuser Plus Standard Procedure Kit	Mckinley Medical, LLC	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1993	1	0
1995	2	0
1998	1	0
1999	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	1
2003	2	0
2004	2	0
2005	4	0
2006	3	0
2008	1	1
2009	1	0
2016	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K020862, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K932740	Homepump NSF Summary page 1 …ion Trade Name: I-Flow Elastomeric Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513, K992072, and K020660 (pending)). Device Description: The \|-Flow Elastomeric Pump consists of an ela…	Block Medical, Inc.	1993	5
*	K944692	C-Series Homepump Summary page 1 …e Name: I-Flow Elastomeric Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513, K992072, and K020660 (pending)). Device Description: The \|-Flow Elastomeric Pump consists of an elastomeric…	Block Medical, Inc.	1995	—
*	K984502	Nerve Block Infusion Kit Summary page 1 …-Flow Elastomeric Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513, K992072, and K020660 (pending)). Device Description: The \|-Flow Elastomeric Pump consists of an elastomeric pressure…	I-Flow Corp.	1999	—
*	K991513	Homepump C-Series and Homepump C-Series One-Step Kvo Summary page 1 …stomeric Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513, K992072, and K020660 (pending)). Device Description: The \|-Flow Elastomeric Pump consists of an elastomeric pressure source wi…	I-Flow Corp.	1999	1
*	K992072	Bolus Accessory Set Summary page 1 …Pump Common Name: Infusion Pump and Administration Set Classification Name: Pump, Infusion Existing Device: I-Flow Elastomeric Pump (K932740, K944692, K984502, K991513, K992072, and K020660 (pending)). Device Description: The \|-Flow Elastomeric Pump consists of an elastomeric pressure source with an int…	I-Flow Corp.	1999	—

Also cleared against K932740: 2 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	17
K023318	I-Flow Elastomeric Pump with Bolus Class I	I-Flow Corp.	2002	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 19, 2002	Not classified	Z-0312-04	Other	Slower than expected infusion of medications, such as antibiotics.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K023318I-Flow Elastomeric Pump with BolusI-Flow Corp. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 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 3.1 years on median.
3 of the 13 ancestors have a recall of any class.
Of its descendants, K023098 (Mckinley Infuser, 2002) has gone furthest, with 17 descendants of its own.
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

2007high 5 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEB

42in 2007

2007high 42 (2007)2026

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

Recalls per year · MEB

17in 2018

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	42	1	110
2008	2	—	3	444
2009	1	—	48	798
2010	0	—	2	1,827
2011	0	—	8 (1)	2,265
2012	0	—	0	1,976
2013	1	—	2 (1)	1,956
2014	1	—	0	2,695
2015	0	—	0	2,980
2016	1	—	0	2,147
2017	0	—	0	1,653
2018	0	—	17	1,473
2019	1	—	0	974
2020	0	—	0	2,732
2021	0	—	0	1,802
2022	0	—	0	1,288
2023	0	—	0	1,248
2024	2	—	0	1,424
2025	0	—	0	1,408
2026	1	—	0	—

What is it indicated for?

The I-Flow 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.

The I-Flow 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.

https://510kreport.com/device/K020862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020862: I-Flow Elastomeric Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020862

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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