510(k) · Cleared
Recalled · Class II · 2018Modification to Autofuser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Us, LLC · MEB Pump, Infusion, Elastomeric
Cleared on Apr 30, 2009 as substantially equivalent to K060258 (Ace Medical Us, LLC, 2006) after an 83-day review. Its family tree reaches back 8 generations to 1990. It has been recalled 16 times.
- Decided
- Apr 30, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896422 (1990). 21 ancestors in all, the oldest K884505 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 7 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 6 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 5 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 4 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 3 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 2 generations backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- 1 generation backK060258 AutofuserAce Medical Us, LLC · 2006 · Recalled
- This deviceK090300 Modification to AutofuserAce Medical Us, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −7 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −6 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −5 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −4 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −3 | 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 | — |
| −1 | K060258 | Autofuser | Ace Medical Us, LLC | 2006 | 46 |
| 0 (this device) | K090300 | Modification to Autofuser | Ace Medical Us, LLC | 2009 | — |
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 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K060258 | AutofuserSummary page 1…Regulation Number: 880.5725 Classification Panel: 80, General Hospital and Personal Use Device Predicate Device Ace Medical Autofluser Elastomeric Infusion Pump System (K060258) Intended Use / Indications for Use The Autofuser family of ambulatory infusion pumps with integrated administration set, eithe… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2018 | Class II | Z-0943-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0949-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0950-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0955-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0956-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0940-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0941-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0942-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0946-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0954-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0945-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0948-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0953-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0947-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0951-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
| Oct 2, 2018 | Class II | Z-0952-2019 | Process control | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it… |
The 5 latest of 16 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 19 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 21 ancestors have a recall of any class.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 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 epidural, 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/K090300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090300: Modification to Autofuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090300
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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