510(k) · Cleared
ClearedAchieve Advance Mapping Catheter
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 Nov 15, 2016 as substantially equivalent to K153139 (Medtronic, Inc., 2016) after a 29-day review. Its family tree reaches back 2 generations to 2011. 1 of the 9 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Nov 15, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K102588 (2011). 6 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK102588 Achieve Mapping Catheter and Electrical CableMedtronic Ablation Frontiers, LLC · 2011 · Recalled
- 1 generation backK153139 Achieve ST Mapping Catheter, Catheter Connecting CableMedtronic, Inc. · 2016
- This deviceK162892 Achieve Advance Mapping CatheterMedtronic, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™…Boston Scientific Corporation · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK233248 FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK262165 FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK250529 Globe Introducer (601-01001)Kardium, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233900 Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223824 POLARSHEATH™ Steerable Sheath 12F…cites it directly · 2023
Most influential descendants
Showing 5 of 6 · See all- K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping…Boston Scientific Corporation · 2023 · cites it directly3descendants
- K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 2023 · 2 generations on2descendants
- K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026 · 3 generations on0descendants
- K250529Globe Introducer (601-01001)Kardium, Inc. · 2025 · 3 generations on0descendants
- K233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K102588 | Achieve Mapping Catheter and Electrical Cable | Medtronic Ablation Frontiers, LLC | 2011 | 1 |
| −1 | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable | Medtronic, Inc. | 2016 | — |
| 0 (this device) | K162892 | Achieve Advance Mapping Catheter | Medtronic, Inc. | 2016 | — |
| +1 | K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular… | Boston Scientific Corporation | 2023 | Class I |
| +2 | K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023 | 3 |
| +3 | K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026 | — |
| +3 | K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025 | — |
| +1 | K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K153139 | Achieve ST Mapping Catheter, Catheter Connecting CableSummary page 4…Recording Catheter Classification & Panel: Class II, 21 CFR 870.1220 Product Code: DRF Predicate Device(s): Achieve™ ST Mapping Catheter (K153139) Device Description: The Achieve Advance Mapping diagnostic catheter is an intra‐ cardiac… | 2016 |
What descends from it? (6)
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 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 11 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 5.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K223824 (Boston Scientific Corporation, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K153139.
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 Achieve Advance mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Advance 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/K162892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162892: Achieve Advance Mapping Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162892
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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