510(k) · Cleared
Recalled · 2008Vanguard Reprocessed Suture Passer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Oct 11, 2006 as substantially equivalent to K980123 (Louisville Laboratories, Inc., 1998) after a 292-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Oct 11, 2006
- Review
- 292 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980123 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980123 Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 1998 · Recalled
- This deviceK053585 Vanguard Reprocessed Suture PasserAscent Healthcare Solutions · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980123 | Carter-Thomason Needle-Point Suture Passer Instrument Set | Louisville Laboratories, Inc. | 1998 | 1 |
| 0 (this device) | K053585 | Vanguard Reprocessed Suture Passer | Ascent Healthcare Solutions | 2006 | — |
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 NLM? 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 NLM device
- #1 K201511 Reprocessed Endoscopic Trocars and Sleevesscore -1.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K980123 | Carter-Thomason Needle-Point Suture Passer Instrument SetSummary page 1…edicate * Trade Names: Devices o Inlet Medical, Inc. CloseSure® Procedure Kit * 510(k) numbers: o K980123: Louisville Laboratories, Inc. (Inlet Medical, Inc.) Carter-Thomason Needle-Point Suture Passer Inst… | 1998 |
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 |
|---|---|---|---|---|
| Mar 11, 2008 | Not classified | Z-1674-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K980123.
How does its category compare?
All NLM devicesNLM Laparoscope, General & Plastic Surgery, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NLM
284in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLM
6so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLM
10in 2025
MAUDE reports naming product code NLM, 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 | 4 | 284 | 0 | 2 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 11 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 1 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 2 | — | 1 | 39 |
| 2017 | 2 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 6 | — |
What is it indicated for?
Reprocessed Suture Passers are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053585: Vanguard Reprocessed Suture Passer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053585
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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