510(k) · Cleared
Recalled · 2007Homepump NSF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Block Medical, Inc. · MED Sterilant, Medical Devices
Cleared on Oct 6, 1993 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 49 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 6, 1993
- Review
- 120 days
- Class
- Class II
- Product code
- MED
- Recalls
- 5
- Predicates
- 0
48 later devices descend from it, 3 citing it directly. 2 of the 49 devices in this family, counting this one, have a Class I recall.
- This deviceK932740 Homepump NSFBlock Medical, Inc. · 1993
- Descendant · cites it directly · 47 of its ownK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- Descendant · 2 generations on · 42 of its ownK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- Descendant · 2 generations on · 33 of its ownK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- Descendant · cites it directly · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- Descendant · 2 generations on · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K980558Painbuster Infusion SystemI-Flow Corp. · 1998 · cites it directly47descendants
- K982946Painbuster Infusion KitI-Flow Corp. · 1998 · 2 generations on42descendants
- K984502Nerve Block Infusion KitI-Flow Corp. · 1999 · 2 generations on33descendants
- K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · cites it directly19descendants
- K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932740 | Homepump NSF | Block Medical, Inc. | 1993 | — |
| +1 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| +2 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| +2 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| +1 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| +2 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2002 | 7 | 1 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (48)
See all 483 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2007 | Not classified | Z-0057-2008 | Process control | 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… |
| Nov 29, 2006 | Not classified | Z-0358-2007 | Other | 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 | Other | The sterile pack may contain the wrong infusion pump inside. |
| Jan 17, 2006 | Not classified | Z-0585-06 | Other | The sterile pack may contain the wrong infusion pump inside. |
| Mar 4, 2003 | Not classified | Z-0687-03 | Other | Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K980558 (I-Flow Corp., 1998) has gone furthest, with 47 descendants of its own.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K932740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932740: Homepump NSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932740
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026