510(k) · Cleared
ClearedCandela Introducer Sheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Laser Corp. · FDE Laparoscopy Kit
Cleared on Aug 16, 1991 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- Aug 16, 1991
- Review
- 74 days
- Class
- Class II
- Product code
- FDE
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK912443 Candela Introducer Sheath SystemCandela Laser Corp. · 1991
- Descendant · cites it directly · 0 of its ownK955717 Endoscope Introducer KitMitsubishi Cable America, Inc. · 1996
Most influential descendants
Showing 1 of 1 · See all- K955717Endoscope Introducer KitMitsubishi Cable America, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912443 | Candela Introducer Sheath System | Candela Laser Corp. | 1991 | — |
| +1 | K955717 | Endoscope Introducer Kit | Mitsubishi Cable America, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 FDE? 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?
FDA lists a 510(k) statement for it but has not posted the file, 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 |
|---|---|---|---|
| K955717 | Endoscope Introducer Kit | 1996 | 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?
- Of its descendants, K955717 (Mitsubishi Cable America, Inc., 1996) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FDE devicesFDE Laparoscopy Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDE
FDA has decided no FDE device since 2007.
Median 510(k) review, days · FDE
Too few FDE 510(k)s in any year since 2007 to give a median.
Recalls per year · FDE
3in 2025
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FDE
17in 2025
MAUDE reports naming product code FDE, 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 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 18 (18) | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 1 | 14 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 17 |
| 2023 | 0 | — | 4 | 23 |
| 2024 | 0 | — | 7 | 56 |
| 2025 | 0 | — | 3 (1) | 17 |
| 2026 | 0 | — | 16 | — |
https://510kreport.com/device/K912443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912443: Candela Introducer Sheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912443
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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