510(k) · Cleared
ClearedModification to Medamicus Axia RSN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medamicus, Inc. · DYB Introducer, Catheter
Cleared on Aug 23, 2002 as substantially equivalent to K020563 (Medamicus, Inc., 2002) after a 10-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 23, 2002
- Review
- 10 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971165 (1997). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971165 Introducer Sheath and DilatorBoston Scientific Corp · 1997
- 1 generation backK020563 Medamicus Axia RSNMedamicus, Inc. · 2002
- This deviceK022689 Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK040029 Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971165 | Introducer Sheath and Dilator | Boston Scientific Corp | 1997 | — |
| −1 | K020563 | Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
| 0 (this device) | K022689 | Modification to Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
| +1 | K040029 | Safetynet Guidewire Introducer | Injectimed, Inc. | 2004 | — |
| +2 | K073664 | Frontline Medical Safetynet Guidewire Introducer | Injectimed, Inc. | 2008 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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 DYB? 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020563 | Medamicus Axia RSN | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040029 | Safetynet Guidewire Introducer | 2004 | 1 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040029 (Injectimed, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K020563.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The MedAmicus Axia RSN is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022689: Modification to Medamicus Axia RSN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022689
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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