510(k) Report

FDA product code · Obstetrics and gynecology

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

OTPClass III21 CFR 884.5980PMA required31 decisions since 20030 recalls

31 FDA decisions since 2003. No recall names this code. The most-cited predicate is K040537, named by 5 later devices.

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

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

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of OTP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OTP

2in 2012

2007: 42008: 82009: 62011: 52012: 2
2007high 8 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTP

71in 2011

2007: 90 days median2008: 103 days median2009: 21 days median2011: 71 days median
2007high 103 (2008) · low 21 (2009)2026

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

Recalls per year · OTP

No recall names OTP since 2007.

Adverse event reports per year · OTP

26in 2025

2007: 12009: 32010: 32011: 322012: 4942013: 7,1502014: 7782015: 6842016: 4152017: 2732018: 3922019: 3682020: 1752021: 6472022: 1142023: 592024: 352025: 26
2007high 7,150 (2013) · low 0 (2008)2025

MAUDE reports naming product code OTP, 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
200749001
2008810300
200962103
20100—03
2011571032
20122—0494
20130—07,150
20140—0778
20150—0684
20160—0415
20170—0273
20180—0392
20190—0368
20200—0175
20210—0647
20220—0114
20230—059
20240—035
20250—026
20260—0—
FIG. 1 — OTP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OTP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OTP devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 20045cite it
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 20045cite it
  • K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 20035cite it
  • K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 20085cite it
  • K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 20044cite it
  • K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 20094cite it

Which OTP devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation · 201213generations
  • K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems · 201213generations
  • K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 201112generations
  • K102815Surelift Prolapse SystemNeomedic International · 201112generations
  • K082730Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate Apical and Posterior…American Medical Systems, Inc. · 200812generations
  • K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp. · 201111generations

What has FDA decided in OTP lately?

  • K122459Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation · 20122 recalls
  • K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems · 2012
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K103426Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
  • K112386Exair Anterior and Posterior Prolapse Repair SystemColoplast Corp. · 2011
  • K102815Surelift Prolapse SystemNeomedic International · 2011

All 31 OTP decisions →

Related product codes

Other codes under 21 CFR 884.5980.

PAI Mesh, Surgical, Non-Synthetic, Urogynecologic…