510(k) · Cleared
Recalled · Class III · 2013Suture Removal Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superior Plastic Products Corp. · KDD Kit, Surgical Instrument, Disposable
Cleared on Jan 12, 1977 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Jan 12, 1977
- Review
- 37 days
- Class
- Class I
- Product code
- KDD
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 KDD? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2013 | Class III | Z-1304-2013 | Error in labeling | On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KDD devicesKDD Kit, Surgical Instrument, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDD
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · KDD
Too few KDD 510(k)s in any year since 2007 to give a median.
Recalls per year · KDD
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KDD
33in 2025
MAUDE reports naming product code KDD, 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 | — | 2 | 0 |
| 2008 | 1 | — | 5 | 0 |
| 2009 | 0 | — | 7 | 0 |
| 2010 | 0 | — | 4 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 3 | 54 |
| 2016 | 0 | — | 0 | 33 |
| 2017 | 0 | — | 2 | 12 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 1 | 22 |
| 2020 | 0 | — | 0 | 44 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 1 | 12 |
| 2023 | 0 | — | 1 | 43 |
| 2024 | 0 | — | 5 | 58 |
| 2025 | 0 | — | 1 | 33 |
| 2026 | 0 | — | 12 (1) | — |
https://510kreport.com/device/K761193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K761193: Suture Removal Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K761193
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026