510(k) Report

510(k) · Cleared

Cleared

Safyre Sling System

K020007510(k) TraditionalCleared Mar 21, 200278-day reviewClass II21 CFR 878.3300

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

Promedon · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Mar 21, 2002 as substantially equivalent to K011251 (American Medical Systems, Inc., 2001) and 2 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1998. 7 later devices descend from it.

Decided
Mar 21, 2002
Review
78 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K974098 (1998). 3 ancestors in all. 7 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2003: 2 descendants cleared2009: 2 descendants cleared2008: 2 descendants cleared2010: 1 descendant clearedK974098 · Pubouurethral Sling · ETHICON, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 1 descendant K974098 · Pubouurethral Sling · ETHICON, Inc. · 19980
  1. Root · 1 generation backK974098 Pubouurethral SlingETHICON, Inc. · 1998
  2. This deviceK020007 Safyre Sling SystemPromedon · 2002
  3. Descendant · cites it directly · 4 of its ownK023898 Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003
  4. Descendant · cites it directly · 2 of its ownK073646 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008
  5. Descendant · cites it directly · 1 of its ownK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  6. Descendant · cites it directly · 1 of its ownK073647 Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008
  7. Descendant · cites it directly · 0 of its ownK092233 Surgimesh XDAspide Medical · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 22008: 22009: 22010: 1
2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003 · cites it directly4descendants
  • K073646Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008 · cites it directly2descendants
  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009 · cites it directly1descendant
  • K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008 · cites it directly1descendant
  • K092233Surgimesh XDAspide Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974098Pubouurethral SlingETHICON, Inc.1998—
0 (this device)K020007Safyre Sling SystemPromedon2002—
+1K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.2003—
+1K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.2008—
+1K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.2009—
+1K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.2008—
+1K092233Surgimesh XDAspide Medical2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200820
200920
201010
FIG. 1 — Lineage of K020007, 1998–2010Source: 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 OTN? 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 OTN device

  1. #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 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? (3)

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
*K011251Sparc Sling System
Summary page 1
…ry Name: SAFYRE Sling Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh Identification of Predicate or Legally Marketed Device o SPARC Sling System — K 011251 manufactured by American Medical Systems o Tension Free Vaginal Tape (TVT) System - K 974098 manufactured by Ethicon (J&J) o Bi…
American Medical Systems, Inc.2001—
*K974098Pubouurethral Sling
Summary page 1
…ntification of Predicate or Legally Marketed Device o SPARC Sling System — K 011251 manufactured by American Medical Systems o Tension Free Vaginal Tape (TVT) System - K 974098 manufactured by Ethicon (J&J) o BioSling ~ K010533 — manufactured by InjectX Inc. 'Device Description yre oohssts of a pierced…
ETHICON, Inc.1998—
*K010533Biosling - Bioabsorbable Polymer Sling & Surgical Mesh
Summary page 1
…o SPARC Sling System — K 011251 manufactured by American Medical Systems o Tension Free Vaginal Tape (TVT) System - K 974098 manufactured by Ethicon (J&J) o BioSling ~ K010533 — manufactured by InjectX Inc. 'Device Description yre oohssts of a pierced polypropylene mesh between two silicone . <::q11.!…
Injectx, Inc.2001—

Also cleared against K011251: 12 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K023898Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd.20034
K073646Minitape Urethral SlingMpathy Medical Devices, Ltd.20082
K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091
K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd.20081
K092233Surgimesh XDAspide Medical20100
K033691Safyre VS and Safyre TPromedon20030

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K023898 (Gyne Ideas, Ltd., 2003) has gone furthest, with 4 descendants of its own.
  • 12 other devices also cite its predicate K011251.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OTN

1in 2023

2007: 22008: 32009: 22010: 52011: 42012: 12013: 52014: 12017: 12019: 12020: 12021: 32022: 22023: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2008: 100 days median2010: 25 days median2011: 56 days median2013: 86 days median2021: 89 days median
2007high 100 (2008) · low 25 (2010)2026

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

Recalls per year · OTN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · OTN

458in 2025

2010: 12011: 252012: 8742013: 19,0842014: 2,0632015: 3,9042016: 1,9022017: 6762018: 7372019: 2,4572020: 1,0032021: 2,6062022: 8092023: 1,0762024: 8222025: 458
2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, 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
20072—00
2008310000
20092—00
201052501
2011456025
20121—0874
2013586019,084
20141—12,063
20150—03,904
20160—01,902
20171—0676
20180—0737
20191—02,457
20201—01,003
202138902,606
20222—0809
20231—01,076
20240—0822
20250—0458
20261—0—

What is it indicated for?

Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K011251

12 other devices cite the same predicate.

  • K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  • K063713Ams Smart Sling SystemAmerican Medical Systems, Inc. · 2007
  • K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 20063 recalls
  • K053296Mentor Aris Suprapubic Surgical KitMentor Corporation · 2005
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004

More from Promedon

2 FDA decisions under this applicant name. See the company

  • K033691Safyre VS and Safyre TPromedon · 2003

Recent decisions in OTN

The OTN category page

  • K262284Kim BlueDesarrollo e Investigación Médica Aragonesa S.L. · 2026
  • K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
  • K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
  • K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022
  • K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc. · 2021

https://510kreport.com/device/K020007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020007: Safyre Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020007

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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