510(k) Report

510(k) · Cleared

Cleared

Lukens Stainless Steel Surgical Suture

K930940510(k) TraditionalCleared Dec 17, 1993297-day reviewClass II21 CFR 878.4495

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

Lukens Medical Corp. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Cleared on Dec 17, 1993 after a 297-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Dec 17, 1993
Review
297 days
Class
Class II
Product code
GAQ
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared1990200020102020
  1. This deviceK930940 Lukens Stainless Steel Surgical SutureLukens Medical Corp. · 1993
  2. Descendant · cites it directly · 0 of its ownK141007 Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930940Lukens Stainless Steel Surgical SutureLukens Medical Corp.1993—
+1K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K930940, 1993–2014Source: 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 GAQ? 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 GAQ device

  1. #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp.20140

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, K141007 (Demetech Corp., 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GAQ devices

GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAQ

1in 2022

2007: 12008: 22014: 22017: 12018: 12020: 12022: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAQ

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

Recalls per year · GAQ

2so far in 2026, the most since 2007

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAQ

83in 2025

2007: 72008: 42009: 72010: 132011: 192012: 102013: 162014: 182015: 172016: 232017: 112018: 532019: 762020: 522021: 392022: 702023: 1002024: 1762025: 83
2007high 176 (2024) · low 4 (2008)2025

MAUDE reports naming product code GAQ, 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
20071—07
20082—04
20090—07
20100—013
20110—019
20120—010
20130—016
20142—018
20150—017
20160—023
20171—011
20181—053
20190—076
20201—052
20210—039
20221—070
20230—0100
20240—0176
20250—083
20260—2—

More from Lukens Medical Corp.

8 FDA decisions under this applicant name. See the company

  • K965162Lukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,Coated, Braided-U.S.P.Lukens Medical Corp. · 19971 recall
  • K930941Lukens Polypropylene Monofilament NonabsorbableLukens Medical Corp. · 1993
  • K930944Lukens Surgical Gut SutureLukens Medical Corp. · 1993
  • K930943Lukens Nylon Surgical SutureLukens Medical Corp. · 1993
  • K930945Braided Polyester Surgical SutureLukens Medical Corp. · 1993

Recent decisions in GAQ

The GAQ category page

  • K203855CoNextions TR Tendon Repair SystemConextions Medical · 2022
  • K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd. · 2020
  • K172146MeristeelM/s. Meril Endo Surgery Private Limited. · 2018
  • K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. · 2017
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014

https://510kreport.com/device/K930940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930940: Lukens Stainless Steel Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930940

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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