510(k) · Cleared
ClearedWells Johnson Infusion System, Model 20-6000-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wells Johnson Co. · FRN Pump, Infusion
Cleared on Aug 30, 1999 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Aug 30, 1999
- Review
- 126 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK991437 Wells Johnson Infusion System, Model 20-6000-00Wells Johnson Co. · 1999
- 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) | K991437 | Wells Johnson Infusion System, Model 20-6000-00 | Wells Johnson Co. | 1999 | — |
| +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)
2 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, 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?
Indications for use are: 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/K991437 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991437: Wells Johnson Infusion System, Model 20-6000-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991437
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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