510(k) · Cleared
ClearedNon Absorbable Surgical Nylon Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Haidike Medical Product Co., Ltd. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Dec 22, 2021 as substantially equivalent to K151165 (Aesculap, Inc., 2016) after a 127-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Dec 22, 2021
- Review
- 127 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954808 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK954808 Ussc Polyproplene SutureUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 3 generations backK050947 Modification to: Modified Uss Polypropylene SutureUnited States Surgical, A Division of Tyco Healthc · 2005 · Recalled
- 2 generations backK133890 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014
- 1 generation backK151165 Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016
- This deviceK212603 Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954808 | Ussc Polyproplene Suture | United States Surgical, A Division of Tyco Healthc | 1996 | 1 |
| −3 | K050947 | Modification to: Modified Uss Polypropylene Suture | United States Surgical, A Division of Tyco Healthc | 2005 | 2 |
| −2 | K133890 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2014 | — |
| −1 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016 | — |
| 0 (this device) | K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.8 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureSummary page 5…. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%. 5. Identification of Predicate Device 510(k) Number: K151165 Regulation Number: 21 CFR 878.5020 Classification: II Product Code: GAR Review Panel: General & Plastic Surge… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K151165.
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212603: Non Absorbable Surgical Nylon Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212603
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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