# K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Jan 26, 2007 after 65 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040337 (2004). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052117: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump), I-Flow Corp. (2005) Summary page 1.

## Most influential descendants
- K181360: ON-Q* Pump with Bolus (2019), 0 descendants of its own
- K131247: Multibolus II Disposable Pain Management System (2013), 0 descendants of its own
- K072053: Smartblock Pain Pump (2007), 0 descendants of its own

## Recalls of this device
- Apr 15, 2011 · Not classified · Z-2860-2011: The recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the pat
- Feb 14, 2008 · Not classified · Z-2133-2008: Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
- Feb 12, 2008 · Not classified · Z-1869-2008: The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than

## Indications for use
1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) 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. 2. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Source page: https://510kreport.com/device/K063530
Methodology: https://510kreport.com/methodology