510(k) · Cleared
ClearedAtricure Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · FTD Lamp, Surgical
Cleared on Jun 9, 2011 as substantially equivalent to K041681 (AtriCure, Inc., 2004) after a 58-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 9, 2011
- Review
- 58 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961122 (1996). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K232153AvéliRevelle Aesthetics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961122 | Stryker Knifelight | Stryker Instruments | 1996 | — |
| −1 | K041681 | Atricure Dissector | AtriCure, Inc. | 2004 | — |
| 0 (this device) | K111020 | Atricure Dissector | AtriCure, Inc. | 2011 | — |
| +1 | K232153 | Avéli | Revelle Aesthetics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 FTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K041681 | Atricure DissectorSummary page 1…soft tissue for identification of anatomic structures. Cleared Device The device proposed for modification in this submission is the AtriCure DissectorM (K041681). Device Description The AtriCure Dissectorm is a hand held, single use, surgical articulated dissector with integ… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232153 | Avéli | 2023 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232153 (Revelle Aesthetics, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K041681.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | 1 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AtriCure Dissector is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111020: Atricure Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111020
Report an extraction error
Are you the manufacturer?
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