510(k) · Cleared
ClearedPsi-Tec Peristaltic Infiltration Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · FRN Pump, Infusion
Cleared on Jun 3, 2004 as substantially equivalent to K012044 (Reliance Medical Corp., 2001) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it.
- Decided
- Jun 3, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K991437 (1999). 2 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK991437 Wells Johnson Infusion System, Model 20-6000-00Wells Johnson Co. · 1999
- This deviceK040149 Psi-Tec Peristaltic Infiltration PumpByron Medical · 2004
- Descendant · cites it directly · 2 of its ownK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK121218 Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia…Andrew Technologies, LLC · 2012
- Descendant · 3 generations on · 0 of its ownK130152 Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013
- Descendant · cites it directly · 0 of its ownK101413 Euromi Eva SP6Euromi S.A · 2010
- Descendant · cites it directly · 0 of its ownK071588 Dispenser DP 20Nouvag AG · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC · 2010 · cites it directly2descendants
- K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC · 2012 · 2 generations on1descendant
- K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013 · 3 generations on0descendants
- K101413Euromi Eva SP6Euromi S.A · 2010 · cites it directly0descendants
- K071588Dispenser DP 20Nouvag AG · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991437 | Wells Johnson Infusion System, Model 20-6000-00 | Wells Johnson Co. | 1999 | — |
| 0 (this device) | K040149 | Psi-Tec Peristaltic Infiltration Pump | Byron Medical | 2004 | — |
| +1 | K092066 | Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser… | Andrew Technologies, LLC | 2010 | — |
| +2 | K121218 | Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM… | Andrew Technologies, LLC | 2012 | — |
| +3 | K130152 | Hydrasolve Lipoplasty System | Andrew Technologies, LLC | 2013 | — |
| +1 | K101413 | Euromi Eva SP6 | Euromi S.A | 2010 | — |
| +1 | K071588 | Dispenser DP 20 | Nouvag AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012044 | BI-Phasic InfiltratorSummary page 2…nfiltrator Manufacturer: Reliance Medical 510(k) Number: K012044 Substantial Equivalence Date: August 2 8 th, 2001 Substantial Equivalence Letter:… | 2001 |
| Kept off the family tree | K980394 | Autofuse V Infiltration Pump Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…ation Pump Manufacturer: Randolph- Austin 510(k) Number: K980394 Substantial Equivalence Date: March 25t , 1998 Substantial Equivalence Letter:… | |
| * | K991437 | Wells Johnson Infusion System, Model 20-6000-00Summary page 2…fusion System Manufacturer: Wells-Johnson 510(k) Number: K991437 Substantial Equivalence Date: August 30t ,1999 Substantial Equivalence Letter:… | 1999 |
What descends from it? (6)
4 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K092066 (Andrew Technologies, LLC, 2010) has gone furthest, with 2 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 PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040149: Psi-Tec Peristaltic Infiltration Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040149
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026