510(k) · Cleared

Recalled · 2009

Autofuser

K060258510(k) TraditionalCleared May 30, 2006118-day reviewClass II21 CFR 880.5725Recalls 46

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

Ace Medical Us, LLC · MEB Pump, Infusion, Elastomeric

Cleared on May 30, 2006 as substantially equivalent to K041585 (Algos, LC, 2004) and 5 other predicates after a 118-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it. It has been recalled 46 times.

Decided: May 30, 2006
Review: 118 days
Class: Class II
Product code: MEB
Recalls: 46
Predicates: 6

Its longest line of descent runs back 7 generations to K896422 (1990). 20 ancestors in all, the oldest K884505 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
6 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
5 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
4 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
3 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
2 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
1 generation backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
This deviceK060258 AutofuserAce Medical Us, LLC · 2006
Descendant · cites it directly · 0 of its ownK090300 Modification to AutofuserAce Medical Us, LLC · 2009 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K090300Modification to AutofuserAce Medical Us, LLC · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K896422	Burron Ambulatory Drug Delivery System	Burron Medical, Inc.	1990	—
−6	K980558	Painbuster Infusion System	I-Flow Corp.	1998	—
−5	K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	—
−4	K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	—
−3	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	1
−2	K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	—
−1	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	2003	—
0 (this device)	K060258	Autofuser	Ace Medical Us, LLC	2006	—
+1	K090300	Modification to Autofuser	Ace Medical Us, LLC	2009	16

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	2	0
1993	1	0
1995	2	0
1998	1	0
1999	3	0
2001	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K060258, 1990–2009Source: 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.

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 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

Get a 510(k) Report

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
*	K041585	Autofuser Ambulatory Infusion Pump Summary page 1 …Regulation Number: 880.5725 Classification Panel: 80, General Hospital and Personal Use Device Product code: MEB - Elastomeric Infusion Pump Original cleared 510(k): K041585 Establishment Registration: pending assignment from FDA Owner/Operator Number: 9082449 5. Summary of Safety and Effectivene…	Algos, LC	2004	46
*	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits Summary page 2 …ser (K04 1585). The modified Autofuiser system also demonstrates substantial equivalence to the Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepunip/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546). 5 10(k) Ace M…	Mckinley, Inc.	2003	—
*	K980558	Painbuster Infusion System Summary page 2 …stantial equivalence to the Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepunip/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546). 5 10(k) Ace Medical Autofuser System 5 10(k) Sunumary p. 2 of…	I-Flow Corp.	1998	—
*	K982946	Painbuster Infusion Kit Summary page 2 …equivalence to the Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepunip/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546). 5 10(k) Ace Medical Autofuser System 5 10(k) Sunumary p. 2 of 2…	I-Flow Corp.	1998	—
*	K944692	C-Series Homepump Summary page 2 …ce to the Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepunip/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546). 5 10(k) Ace Medical Autofuser System 5 10(k) Sunumary p. 2 of 2…	Block Medical, Inc.	1995	—
*	K896546	Homepump (Disp. Elastomeric Infusion Device) Summary page 2 …Woo Young/McKinley Medical Accufuser System (K033039), and to the I-Flow Homepunip/Eclipse/OnQ Painbuster system (K980558, K982946, K944692, K896546). 5 10(k) Ace Medical Autofuser System 5 10(k) Sunumary p. 2 of 2…	Block Medical, Inc.	1990	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090300	Modification to Autofuser	Ace Medical Us, LLC	2009	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 14, 2009	Not classified	Z-1846-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1848-2009	Process control	TFailure to infuse and potential compromised sterility: he seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1834-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1840-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1845-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1829-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1862-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1852-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1832-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1868-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1836-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1838-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1859-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1855-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1865-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1847-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1839-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1858-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1863-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1867-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1844-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1856-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1827-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1830-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1837-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1831-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1842-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1826-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1841-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1824-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1861-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1854-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1828-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1851-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1857-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1864-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1835-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1866-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1823-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1849-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1843-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1825-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1860-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1850-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1853-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
May 14, 2009	Not classified	Z-1833-2009	Process control	Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

The 5 latest of 46 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 10 months on median.
5 of the 20 ancestors have a recall of any class.
Of its descendants, K090300 (Ace Medical Us, LLC, 2009) has gone furthest, with 0 descendants of its own.

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 Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidurar, and into intra-operative (soft tissue/body cavity) sites.

Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button.

General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060258: Autofuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060258

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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