510(k) Report

510(k) · Cleared

Cleared

Dacron R Surgical Sutures

K904263510(k) TraditionalCleared Oct 16, 199029-day reviewClass II21 CFR 878.5000

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sharppoint, Inc. · GAS Suture, Nonabsorbable, Synthetic, Polyester

Cleared on Oct 16, 1990 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Oct 16, 1990
Review
29 days
Class
Class II
Product code
GAS
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2008: 1 descendant cleared2023: 2 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK904263 Dacron R Surgical SuturesSharppoint, Inc. · 1990
  2. Descendant · cites it directly · 11 of its ownK060165 Axyaflex Polyester SutureAxya Medical, Inc. · 2006
  3. Descendant · 2 generations on · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
  4. Descendant · 3 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
  5. Descendant · 3 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
  6. Descendant · 4 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12015: 12017: 12018: 22022: 12023: 22024: 2
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K060165Axyaflex Polyester SutureAxya Medical, Inc. · 2006 · cites it directly11descendants
  • K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on9descendants
  • K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 3 generations on4descendants
  • K173747RexleneSm Eng Co., Ltd. · 2018 · 3 generations on1descendant
  • K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904263Dacron R Surgical SuturesSharppoint, Inc.1990—
+1K060165Axyaflex Polyester SutureAxya Medical, Inc.2006—
+2K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc.2008—
+3K161633Rexlon, RexsilSm Eng Co., Ltd.2017—
+3K173747RexleneSm Eng Co., Ltd.2018—
+4K180701SafePath Suturing SystemSafepath Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
201510
201710
201820
202210
202320
202420
FIG. 1 — Lineage of K904263, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GAS? 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 GAS device

  1. #1 K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture…score 1.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060165Axyaflex Polyester SutureAxya Medical, Inc.200611

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, K060165 (Axya Medical, Inc., 2006) has gone furthest, with 11 descendants of its own.

How does its category compare?

All GAS devices

GAS Suture, Nonabsorbable, Synthetic, Polyester: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAS

2in 2020

2010: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAS

Too few GAS 510(k)s in any year since 2007 to give a median.

Recalls per year · GAS

No recall names GAS since 2007.

Adverse event reports per year · GAS

3in 2025

2007: 352008: 472009: 562010: 242011: 252012: 732013: 212014: 122015: 12016: 22018: 32020: 12024: 12025: 3
2007high 73 (2012) · low 0 (2017)2025

MAUDE reports naming product code GAS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—035
20080—047
20090—056
20101—024
20110—025
20120—073
20130—021
20140—012
20150—01
20160—02
20170—00
20180—03
20190—00
20202—01
20210—00
20220—00
20230—00
20240—01
20250—03
20260—0—

Recent decisions in GAS

The GAS category page

  • K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0…Lsi Solutions, Inc. · 2020
  • K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020
  • K091018Arthrex BiowireArthrex, Inc. · 2010
  • K002261MR-IIISmith & Nephew, Inc. · 2000
  • K953128Suture CordPhoenix Biomedical Corp. · 1996

https://510kreport.com/device/K904263 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904263: Dacron R Surgical Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904263

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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