# K932740: Homepump NSF

- Pathway: 510(k) (Traditional)
- Applicant: Block Medical, Inc.
- Decided: Oct 6, 1993 after 120 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 3 cite it directly.
2 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980558: Painbuster Infusion System (1998), 47 descendants of its own
- K982946: Painbuster Infusion Kit (1998), 42 descendants of its own
- K984502: Nerve Block Infusion Kit (1999), 33 descendants of its own
- K020862: I-Flow Elastomeric Pump (2002), 19 descendants of its own
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), 17 descendants of its own

## Recalls of this device
- Mar 27, 2007 · Not classified · Z-0057-2008: Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the
- Nov 29, 2006 · Not classified · Z-0358-2007: The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
- Jan 17, 2006 · Not classified · Z-0584-06: The sterile pack may contain the wrong infusion pump inside.
- Jan 17, 2006 · Not classified · Z-0585-06: The sterile pack may contain the wrong infusion pump inside.
- Mar 4, 2003 · Not classified · Z-0687-03: Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

Source page: https://510kreport.com/device/K932740
Methodology: https://510kreport.com/methodology