# K072053: Smartblock Pain Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medical Flow Systems, Ltd.
- Decided: Nov 6, 2007 after 103 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040337 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump, I-Flow Corp. (2007) Summary page 2.

## Recalls of this device
- Mar 17, 2010 · Not classified · Z-1981-2011: Elastomeric tube in product's compression unit has the potential to burst following filling.
- Jan 8, 2009 · Not classified · Z-1022-2010: Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.

## Indications for use
The SmartBlock Tm Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.

Source page: https://510kreport.com/device/K072053
Methodology: https://510kreport.com/methodology