510(k) · Cleared
ClearedBI-Phasic Infiltrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Corp. · FRN Pump, Infusion
Cleared on Aug 28, 2001 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Aug 28, 2001
- Review
- 60 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK012044 BI-Phasic InfiltratorReliance Medical Corp. · 2001
- Descendant · cites it directly · 6 of its ownK040149 Psi-Tec Peristaltic Infiltration PumpByron Medical · 2004
- Descendant · 2 generations on · 2 of its ownK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK121218 Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia…Andrew Technologies, LLC · 2012
- Descendant · 4 generations on · 0 of its ownK130152 Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK101413 Euromi Eva SP6Euromi S.A · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040149Psi-Tec Peristaltic Infiltration PumpByron Medical · 2004 · cites it directly6descendants
- K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC · 2010 · 2 generations on2descendants
- K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC · 2012 · 3 generations on1descendant
- K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013 · 4 generations on0descendants
- K101413Euromi Eva SP6Euromi S.A · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012044 | BI-Phasic Infiltrator | Reliance Medical Corp. | 2001 | — |
| +1 | K040149 | Psi-Tec Peristaltic Infiltration Pump | Byron Medical | 2004 | — |
| +2 | K092066 | Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser… | Andrew Technologies, LLC | 2010 | — |
| +3 | K121218 | Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM… | Andrew Technologies, LLC | 2012 | — |
| +4 | K130152 | Hydrasolve Lipoplasty System | Andrew Technologies, LLC | 2013 | — |
| +2 | K101413 | Euromi Eva SP6 | Euromi S.A | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040149 | Psi-Tec Peristaltic Infiltration Pump | 2004 | 6 |
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, K040149 (Byron Medical, 2004) has gone furthest, with 6 descendants 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) | — |
What is it indicated for?
The Reliance Medical Bi-Phasic Infiltrator indication for use is:
General surgical fluid irrigation and infiltration.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012044: BI-Phasic Infiltrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012044
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026