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Homepump NSF

by Block Medical, Inc. 510(k)

Active United States

510(k) K932740

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932740 Date6 Oct 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · FDA

    • Terminated Z-0057-2008 FDA Unclassified (pre-2012) initiated 27 Mar 2007

    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 the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.

    • Terminated Z-0358-2007 FDA Unclassified (pre-2012) initiated 29 Nov 2006 on shared 510(k) K932740

    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.

  • 2 recalls, same reason

    • Terminated Z-0584-06 FDA Unclassified (pre-2012) initiated 17 Jan 2006 on shared 510(k) K932740
    • Terminated Z-0585-06 FDA Unclassified (pre-2012) initiated 17 Jan 2006 on shared 510(k) K932740

    The sterile pack may contain the wrong infusion pump inside.

    • Terminated Z-0687-03 FDA Unclassified (pre-2012) initiated 4 Mar 2003 on shared 510(k) K932740

    Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
MED
Device Class
Class II
Regulation
21 CFR Part 880.6885
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Homepump NSF is an elastomeric infusion device designed for the controlled delivery of fluids, typically used in home healthcare settings to administer medications or fluids at a programmed rate. Its flexible elastomeric reservoir expands and contracts to dispense contents without the need for external power sources, making it portable and suitable for long-term use.

This device is intended for single-use and requires no sterilisation before use, as it is supplied sterile. It is classified as a Class II medical device under FDA regulations (21 CFR 880.6885) and has been cleared via a 510(k) submission (K932740) as substantially equivalent to a predicate device. The Homepump NSF is distributed in various sizes and configurations, as indicated by its registration numbers, and is intended for use in general hospital and home infusion applications.

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