510(k) Report

510(k) · Decided

Decided

Suturegroove Weight Sizing Set

K003646510(k) TraditionalDecided Feb 22, 200187-day reviewClass II21 CFR 886.5700

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

Iop, Inc. · MML Weights, Eyelid, External

Cleared on Feb 22, 2001 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 22, 2001
Review
87 days
Class
Class II
Product code
MML
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K003646Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All MML devices

MML Weights, Eyelid, External: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MML

1in 2017

2015: 12017: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MML

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

Recalls per year · MML

No recall names MML since 2007.

Adverse event reports per year · MML

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code MML, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Iop, Inc.

9 FDA decisions under this applicant name. See the company

  • K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
  • K062252MOLTENO3Iop, Inc. · 20061 recall
  • K053622Surgisis Ocular GraftIop, Inc. · 2006
  • K010852Osmed Tissue ExpanderIop, Inc. · 2001
  • K994289SuturegrooveIop, Inc. · 2000

Recent decisions in MML

The MML category page

  • K170591Altomed Malhotra Platinum SegmentsAltomed Limited · 2017
  • K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 20152 recalls
  • K021750Lid Chain Eyelid WeightsJedmed Instrument Co. · 2003
  • K011740Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
  • K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik · 2001

https://510kreport.com/device/K003646 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003646: Suturegroove Weight Sizing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003646

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026