510(k) · Cleared
ClearedSta Cath Attachable Infision Catheter, Model STA20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Infusion, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Oct 18, 2006 as substantially equivalent to K021964 (Advanced Infusion, Inc., 2002) and 5 other predicates after a 127-day review. Its family tree reaches back 4 generations to 1990. 1 of the 19 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 18, 2006
- Review
- 127 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K896422 (1990). 18 ancestors in all. No later device cites it as a predicate yet. 1 of the 19 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 2 generations backK992551 Alpha Infusion PumpAdvanced Infusion, Inc. · 1999
- 1 generation backK021964 Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
- This deviceK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
Class I recalls in this family
- K990500 Kendall Ultramer Coude Foley Catheter, Model…direct predicate · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −3 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −2 | K992551 | Alpha Infusion Pump | Advanced Infusion, Inc. | 1999 | — |
| −1 | K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | 2002 | — |
| 0 (this device) | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 1 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 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.
1 device in this family has 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K021964 | Alpha Infusion Pump and Catheters | 2002 |
| * | K042264 | GuidewiresSummary page 1…805q725. Product Code \I3B) Predicate I)evices: KO2 1964 - Alpha Infusion Pump and Catheters K042264 - Milhi Drinp Iilniusion CatliheleTS K0039 15 - Accufuser and Accufuser Pius… | 2004 |
| * | K003915 | Accufuser; Accufuser PlusSummary page 1…Infusion Pump and Catheters K042264 - Milhi Drinp Iilniusion CatliheleTS K0039 15 - Accufuser and Accufuser Pius K040260 - hronic I lemodialk sis Catheter… | 2001 |
| * | K040260 | Integral Hemodialysis CatheterSummary page 1…ilhi Drinp Iilniusion CatliheleTS K0039 15 - Accufuser and Accufuser Pius K040260 - hronic I lemodialk sis Catheter K, (1020_ t1emo Split ng-IermI 11ciodial; s… | 2004 |
| Kept off the family tree | K010204 | FDA’s K010204 is Stryker Navigation System-Knee Module Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K020577 | Applied Ureteral CatheterSummary page 1…k sis Catheter K, (1020_ t1emo Split ng-IermI 11ciodial; sis Catheter K020577 -Applied I.'reteral Catheter K990500 - [ ltramer Coude I'olc\ Catheter… | 2002 |
| * | K990500 | Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…Summary page 1…ng-IermI 11ciodial; sis Catheter K020577 -Applied I.'reteral Catheter K990500 - [ ltramer Coude I'olc\ Catheter Dlevice Description: I he S7!I (c alh . t1lloctdule Infusion Cathet… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946CThe Kendal Co. · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 18 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K021964.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STA Cath®Attachable Infusion Catheter is intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The STA Cath Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061661: Sta Cath Attachable Infision Catheter, Model STA20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061661
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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