510(k) · Cleared
ClearedHomepump (Disp. Elastomeric Infusion Device)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Block Medical, Inc. · FRN Pump, Infusion
Cleared on Feb 6, 1990 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 6, 1990
- Review
- 81 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK896546 Homepump (Disp. Elastomeric Infusion Device)Block Medical, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK060258 AutofuserAce Medical Us, LLC · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK971362 Personal InfusorScience Incorporated · 1997
- Descendant · 2 generations on · 0 of its ownK090300 Modification to AutofuserAce Medical Us, LLC · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK052817 Eureka Infusion Pump, Models Eureka-IP, Eureka-LFUniversal Medical Technologies · 2006
- Descendant · 2 generations on · 0 of its ownK990208 Personal Infusor with Drug Disposal Septal PortScience Incorporated · 1999
Most influential descendants
Showing 5 of 5 · See all- K060258AutofuserAce Medical Us, LLC · 2006 · cites it directly1descendant
- K971362Personal InfusorScience Incorporated · 1997 · cites it directly1descendant
- K090300Modification to AutofuserAce Medical Us, LLC · 2009 · 2 generations on0descendants
- K052817Eureka Infusion Pump, Models Eureka-IP, Eureka-LFUniversal Medical Technologies · 2006 · cites it directly0descendants
- K990208Personal Infusor with Drug Disposal Septal PortScience Incorporated · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896546 | Homepump (Disp. Elastomeric Infusion Device) | Block Medical, Inc. | 1990 | — |
| +1 | K060258 | Autofuser | Ace Medical Us, LLC | 2006 | 46 |
| +1 | K971362 | Personal Infusor | Science Incorporated | 1997 | — |
| +2 | K090300 | Modification to Autofuser | Ace Medical Us, LLC | 2009 | 16 |
| +1 | K052817 | Eureka Infusion Pump, Models Eureka-IP, Eureka-LF | Universal Medical Technologies | 2006 | — |
| +2 | K990208 | Personal Infusor with Drug Disposal Septal Port | Science Incorporated | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 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.
Planning a device in FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060258 (Ace Medical Us, LLC, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K896546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896546: Homepump (Disp. Elastomeric Infusion Device).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896546
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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