510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Safil and Safil Quick Synthetic Absorbable Surgical Suture

K031286510(k) SpecialCleared May 29, 200336-day reviewClass II21 CFR 878.4493Recalls 1

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

Aesculap, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

Cleared on May 29, 2003 as substantially equivalent to K011372 (Aesculap, Inc., 2001) and 4 other predicates after a 36-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it. It has been recalled once.

Decided
May 29, 2003
Review
36 days
Class
Class II
Product code
GAM
Recalls
1
Predicates
5

Its longest line of descent runs back 1 generation to K944110 (1995). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor2024: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant clearedK944110 · Vicryl Rapide Suture · ETHICON, Inc. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K944110 · Vicryl Rapide Suture · ETHICON, Inc. · 1995 · recalled0
  1. Root · 1 generation backK944110 Vicryl Rapide SutureETHICON, Inc. · 1995 · Recalled
  2. This deviceK031286 Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003
  3. Descendant · cites it directly · 1 of its ownK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
  4. Descendant · cites it directly · 0 of its ownK233265 Monotime and Optime RPeters Surgical · 2024
  5. Descendant · 2 generations on · 0 of its ownK073493 Hepatostat SetVygon Corp. · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K061796Hepatostat Set, Model 760XVygon Corp. · 2006 · cites it directly1descendant
  • K233265Monotime and Optime RPeters Surgical · 2024 · cites it directly0descendants
  • K073493Hepatostat SetVygon Corp. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944110Vicryl Rapide SutureETHICON, Inc.19952
0 (this device)K031286Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc.2003—
+1K061796Hepatostat Set, Model 760XVygon Corp.2006—
+1K233265Monotime and Optime RPeters Surgical2024—
+2K073493Hepatostat SetVygon Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
202410
FIG. 1 — Lineage of K031286, 1995–2024Source: 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), 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 GAM? 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 GAM device

  1. #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011372Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc.2001—
*K980704Safil Synthetic Absorbable Surgical Suture
Summary page 1
…Quick Absorbable Surgical Suture is substantially equivalent to Safil Synthetic Absorbable Surgical Suture (KO1 1372), Safil Quick Synthetic Absorbable Surgical Suture (K980704) and the following other predicate devices: 0 Vicryl Synthetic Absorbable Surgical Suture (K944110 and K962480) 0…
Aesculap, Inc.1998—
*K944110Vicryl Rapide Suture
Summary page 1
…(KO1 1372), Safil Quick Synthetic Absorbable Surgical Suture (K980704) and the following other predicate devices: 0 Vicryl Synthetic Absorbable Surgical Suture (K944110 and K962480) 0 MonoSyn Synthetic Absorbable Surgical Suture (KO11375)…
ETHICON, Inc.19952
*K962480Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed
Summary page 1
…Safil Quick Synthetic Absorbable Surgical Suture (K980704) and the following other predicate devices: 0 Vicryl Synthetic Absorbable Surgical Suture (K944110 and K962480) 0 MonoSyn Synthetic Absorbable Surgical Suture (KO11375) 6 ===…
ETHICON, Inc.19962
*K011375Aesculap, Inc., Monosyn Synthetic Absorbable Surgical SutureAesculap, Inc.2001—

Also cleared against K011372: 1 other device →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061796Hepatostat Set, Model 760XVygon Corp.20061
K233265Monotime and Optime RPeters Surgical20240

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 1, 2016Class IIZ-0316-2017Process controlThere is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K061796 (Vygon Corp., 2006) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K011372.

How does its category compare?

All GAM devices

GAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAM

3in 2025

2007: 72008: 62009: 32010: 12011: 22012: 52013: 12014: 102015: 52016: 32017: 82018: 52019: 42020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 10 (2014) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAM

29in 2025

2007: 50 days median2008: 174 days median2009: 10 days median2012: 31 days median2014: 121 days median2015: 209 days median2016: 169 days median2017: 134 days median2018: 98 days median2019: 90 days median2020: 140 days median2025: 29 days median2026 (partial year): 131 days median
2007high 209 (2015) · low 10 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GAM

1in 2024

2007: 102008: 12009: 62010: 32011: 62016: 12017: 12019: 12020: 442022: 42024: 12026 (partial year): 2
2007high 44 (2020) · low 0 (2012)2026

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

Adverse event reports per year · GAM

8,970in 2025

2007: 2742008: 1942009: 2872010: 5872011: 6372012: 8682013: 8982014: 1,4102015: 9352016: 1,1122017: 1,4992018: 2,2292019: 3,5642020: 3,4152021: 4,5062022: 4,8142023: 5,0702024: 7,2262025: 8,970
2007high 8,970 (2025) · low 194 (2008)2025

MAUDE reports naming product code GAM, 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
200775010274
200861741194
20093106287
20101—3587
20112—6637
20125310868
20131—0898
20141012101,410
201552090935
2016316911,112
2017813411,499
201859802,229
201949013,564
20203140443,415
20212—04,506
20222—44,814
20231—05,070
20242—17,226
202532908,970
202641312—

What is it indicated for?

Safil and Safil Quick sutures are indicated for use in general soft tissue approximation,

including ophthalmic procedures, but not in cardiovascular or neurological procedures.

Indications for use as stated in the FDA summary.

Also cleared against K011372

1 other device cites the same predicate.

  • K143584Pga Resorba, Pga Resoquick, GlycolonResorba Medical GmbH · 2015

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in GAM

The GAM category page

  • K263073Fast Absorbing PGLARiverpoint Medical, LLC · 2026
  • K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc. · 2026
  • K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic · 2026
  • K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. · 2026
  • K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue…ETHICON, Inc. · 2025

https://510kreport.com/device/K031286 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031286: Safil and Safil Quick Synthetic Absorbable 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/K031286

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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