510(k) · Cleared

Cleared

Nerve Block Infusion Kit

K984502510(k) TraditionalCleared Mar 4, 199976-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 4, 1999 as substantially equivalent to K980558 (I-Flow Corp., 1998) and 4 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1990. 2 of the 40 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.

Decided: Mar 4, 1999
Review: 76 days
Class: Class II
Product code: MEB
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K896422 (1990). 6 ancestors in all. 33 later devices descend from it, 4 citing it directly. 2 of the 40 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
2 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
1 generation backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
This deviceK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
Descendant · cites it directly · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
Descendant · 2 generations on · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
Descendant · 3 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
Descendant · cites it directly · 10 of its ownK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
Descendant · 2 generations on · 9 of its ownK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2002high 6 (2005) · low 0 (2010)2026

Class I recalls in this family

K023318 I-Flow Elastomeric Pump with Bolus2 generations on · 2002
K081905 Accuflow and Accuflux Elastomeric Infusion Pump6 generations on · 2008

Most influential descendants

Showing 5 of 33 · See all

K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · cites it directly19descendants
K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 2 generations on17descendants
K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 3 generations on15descendants
K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003 · cites it directly10descendants
K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K896422	Burron Ambulatory Drug Delivery System	Burron Medical, Inc.	1990	—
−2	K980558	Painbuster Infusion System	I-Flow Corp.	1998	—
−1	K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	—
0 (this device)	K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	—
+1	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	1
+2	K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	—
+3	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	2003	—
+1	K030830	B. Braun Nerve Block Catheter	B.Braun Medical, Inc.	2003	—
+2	K042488	Perifix Catheter and Contiplex Catheter	B.Braun Medical, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	1
2003	3	0
2004	3	0
2005	6	0
2006	5	0
2007	1	0
2008	2	1
2009	2	0
2011	1	0
2016	3	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K984502, 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K980558	Painbuster Infusion System Summary page 1 …1.2 Statement of Equivalence 1.2.1 The Nerve Block Infusion Kit is substantially equivalent in total or in part to the following: the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continu…	I-Flow Corp.	1998	—
*	K982946	Painbuster Infusion Kit Summary page 1 …tement of Equivalence 1.2.1 The Nerve Block Infusion Kit is substantially equivalent in total or in part to the following: the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continuous Nerve…	I-Flow Corp.	1998	—
*	K896422	Burron Ambulatory Drug Delivery System Summary page 1 …is substantially equivalent in total or in part to the following: the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continuous Nerve Block Set (pre-amendment device) and the McKinley Outboun…	Burron Medical, Inc.	1990	—
*	K944692	C-Series Homepump Summary page 1 …in part to the following: the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continuous Nerve Block Set (pre-amendment device) and the McKinley Outbound Syringe Infuser (K982256). 1.2.2 The…	Block Medical, Inc.	1995	—
*	K982256	Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump Summary page 1 …Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continuous Nerve Block Set (pre-amendment device) and the McKinley Outbound Syringe Infuser (K982256). 1.2.2 The Nerve Block Infusion Kit includes components that are legally marketed (either pre-amendment devices or devices tha…	Mckinley, Inc.	1998	—
*	—	B. Braun Continuous Nerve Block Set Named without a submission number			—

Also cleared against K980558: 6 other devices →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	19
K030830	B. Braun Nerve Block Catheter	B.Braun Medical, Inc.	2003	10
K060933	Solace Post-Operative Pain Relief Infusion System	Apex Medical Technologies, Inc.	2006	0
K020660	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo	I-Flow Corp.	2002	0

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

No FDA recall names this device.

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 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 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.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K020862 (I-Flow Corp., 2002) has gone furthest, with 19 descendants of its own.
6 other devices also cite its predicate K980558.

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 Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into intraoperative sites.

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/K984502 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984502: Nerve Block 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/K984502

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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