510(k) · Cleared
Recalled · Class II · 2014Cardioflon, Cardioxyl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peters Surgical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Oct 11, 2006 as substantially equivalent to K913101 (Promedica Products, Inc., 1992) and 1 other predicate after a 261-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 2 times.
- Decided
- Oct 11, 2006
- Review
- 261 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913101 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK913101 Peters Cardioflon (TM) SuturePromedica Products, Inc. · 1992
- This deviceK060163 Cardioflon, CardioxylPeters Surgical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913101 | Peters Cardioflon (TM) Suture | Promedica Products, Inc. | 1992 | — |
| 0 (this device) | K060163 | Cardioflon, Cardioxyl | Peters Surgical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 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? (2)
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 |
|---|---|---|---|
| * | K913101 | Peters Cardioflon (TM) SutureSummary page 2…Panel, Nonabsorbable Polyester Surgical Suture (GAS). Predicate Device Name PETERS CARDIOFLON® SUTURE, Nonabsorbable Polyester Synthetic Suture (K913101). TIoCRON , Nonabsorbable Polyethylene Surgical Suture (K930591). Statement of intended use CARDIOFLON® and CARD… | 1992 |
| * | K930591 | TI-Cron and Dacron SuturesSummary page 2…te Device Name PETERS CARDIOFLON® SUTURE, Nonabsorbable Polyester Synthetic Suture (K913101). TIoCRON , Nonabsorbable Polyethylene Surgical Suture (K930591). Statement of intended use CARDIOFLON® and CARDIOXYL® sutures are intended for use in general soft tissue approx… | 1993 |
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 |
|---|---|---|---|---|
| Jun 25, 2014 | Class II | Z-2676-2014 | Process control | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| Jun 25, 2014 | Class II | Z-2675-2014 | Process control | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The CARDIOFLON® and CARDIOXYL sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060163: Cardioflon, Cardioxyl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060163
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