510(k) · Cleared
Recalled · Class II · 2018Surgical Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical · DRC Trocar
Cleared on Apr 22, 1991 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 22, 1991
- Review
- 19 days
- Class
- Class II
- Product code
- DRC
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK911462 Surgical TrocarApplied Medical · 1991
- Descendant · cites it directly · 0 of its ownK133375 Banyan Medical Disposable Secondary Cannula and TrocarBanyan Medical, LLC · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K133375Banyan Medical Disposable Secondary Cannula and TrocarBanyan Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911462 | Surgical Trocar | Applied Medical | 1991 | — |
| +1 | K133375 | Banyan Medical Disposable Secondary Cannula and Trocar | Banyan Medical, LLC | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRC? 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 DRC device
- #1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K133375 | Banyan Medical Disposable Secondary Cannula and Trocar | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2018 | Class II | Z-1584-2018 | Under Investigation by firm | Products have been packaged with the wrong Trocar length type. |
| Sep 13, 2013 | Class II | Z-0147-2015 | Error in labeling | CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133375 (Banyan Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRC
Too few DRC 510(k)s in any year since 2007 to give a median.
Recalls per year · DRC
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRC
69in 2025
MAUDE reports naming product code DRC, 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 | — | 0 | 106 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 17 |
| 2010 | 0 | — | 1 | 33 |
| 2011 | 1 | — | 0 | 68 |
| 2012 | 1 | — | 0 | 58 |
| 2013 | 1 | — | 1 | 37 |
| 2014 | 2 | — | 1 | 65 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 62 |
| 2017 | 2 | — | 0 | 70 |
| 2018 | 2 | — | 0 | 85 |
| 2019 | 0 | — | 1 (1) | 95 |
| 2020 | 0 | — | 0 | 108 |
| 2021 | 1 | — | 1 | 78 |
| 2022 | 2 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 109 |
| 2024 | 2 | — | 0 | 105 |
| 2025 | 0 | — | 0 | 69 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K911462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911462: Surgical Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911462
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026