510(k) · Cleared
ClearedAchieve ST Mapping Catheter, Catheter Connecting Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on May 6, 2016 as substantially equivalent to K102588 (Medtronic Ablation Frontiers, LLC, 2011) after a 189-day review. Its family tree reaches back 1 generation to 2011. 1 of the 12 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- May 6, 2016
- Review
- 189 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102588 (2011). 10 later devices descend from it, 3 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK102588 Achieve Mapping Catheter and Electrical CableMedtronic Ablation Frontiers, LLC · 2011 · Recalled
- This deviceK153139 Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK162892 Achieve Advance Mapping CatheterMedtronic, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK193263 Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC · 2020
- Descendant · 4 generations on · 0 of its ownK262165 FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223824 POLARSHEATH™ Steerable Sheath 12F…2 generations on · 2023
Most influential descendants
Showing 5 of 10 · See all- K162892Achieve Advance Mapping CatheterMedtronic, Inc. · 2016 · cites it directly6descendants
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation · 2023 · 2 generations on3descendants
- K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · 3 generations on2descendants
- K193263Reprocessed Achieve Catheter Connecting CableInnovative Health, LLC · 2020 · cites it directly1descendant
- K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102588 | Achieve Mapping Catheter and Electrical Cable | Medtronic Ablation Frontiers, LLC | 2011 | 1 |
| 0 (this device) | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | 2016 | — |
| +1 | K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | 2016 | — |
| +2 | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | Class I |
| +3 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| +1 | K193263 | Reprocessed Achieve Catheter Connecting Cable | Innovative Health, LLC | 2020 | — |
| +4 | K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · 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 |
|---|---|---|---|
| * | K102588 | Achieve Mapping Catheter and Electrical CableSummary page 4…Electrode Recording Catheter Classification & Panel: Class II, 21 CFR 870.1220 Product Code: DRF Predicate Device(s): Achieve™ Mapping Catheter K102588 Device Description: The Achieve ST Mapping diagnostic catheter is an intra‐cardiac electrophysio… | 2011 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K162892 (Medtronic, Inc., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AchieveTM ST mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The AchieveTM ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153139: Achieve ST Mapping Catheter, Catheter Connecting Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153139
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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