510(k) · Cleared
ClearedSemperflo Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Mar 22, 2006 after a 148-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 22, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (3)
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 |
|---|---|---|---|
| * | — | On-Q Pain Pump Named without a submission number | |
| * | — | VICRYL* Suture Named without a submission number | |
| * | — | BAXTER Pain Management System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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 SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate. The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings. The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat…
Read the full statement (155 words)
The SEMPERFLO Infusion System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate.
The device is intended for intraoperative placement in hospital or alternate medical site environments. Once implanted, the device and pump may be used in homecare settings.
The device is not intended for intravascular, intrathecal, or epidural use, nor is it indicated for use with blood, blood products, lipids or fat emulsions.
When packaged in the kit configuration for pain management (to be known as the SEMPERFLO* Pain Management System), the intended use will be as follows:
The SEMPERFLO Pain Management System is intended to provide continuous percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The SEMPERFLO Pain Management System is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or in close proximity to nerves when compared with narcotic only pain management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052999: Semperflo Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026