510(k) · Cleared
Recalled · 2010Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precise Medical Products, Ltd. · MEB Pump, Infusion, Elastomeric
Cleared on Jun 16, 2006 as substantially equivalent to K042122 (Precise Medical Products, 2004) after a 25-day review. Its family tree reaches back 4 generations to 1990. It has been recalled 2 times.
- Decided
- Jun 16, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- MEB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896422 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 backK042122 Smartinfuser PainpumpPrecise Medical Products · 2004 · Recalled
- This deviceK061409 Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O…Precise Medical Products, Ltd. · 2006
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 | K042122 | Smartinfuser Painpump | Precise Medical Products | 2004 | 1 |
| 0 (this device) | K061409 | Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set | Precise Medical Products, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K042122 | Smartinfuser PainpumpSummary page 2…ass: H Panel identification: General Hospital Panel Predicate Device: SmartInfuser PainPump TM , Precise Medical Products Ltd, Shlomi, Israel, cleared under 510(k) no. K042122. Description of the device: The device comprises of the following parts: - SmartCatheter (optional) - SmartInfuser set with… | 2004 |
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 |
|---|---|---|---|---|
| Mar 17, 2010 | Not classified | Z-1982-2011 | Other | Elastomeric tube in product's compression unit has the potential to burst following filling. |
| Jan 8, 2009 | Not classified | Z-1021-2010 | Process control | Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 6 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.
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 SmartInfuser PainPump Tm is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061409: Smartinfuser Painpump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061409
Report an extraction error
Are you the manufacturer?
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