510(k) Report

510(k) · Cleared

Cleared

Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010

K011115510(k) SpecialCleared May 2, 200120-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

Heinz Kurz GmbH Medizintechnik · MML Weights, Eyelid, External

Cleared on May 2, 2001 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
May 2, 2001
Review
20 days
Class
Class II
Product code
MML
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared200020052010201520202025
  1. This deviceK011115 Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007…Heinz Kurz GmbH Medizintechnik · 2001
  2. Descendant · cites it directly · 0 of its ownK170591 Altomed Malhotra Platinum SegmentsAltomed Limited · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K170591Altomed Malhotra Platinum SegmentsAltomed Limited · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011115Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007…Heinz Kurz GmbH Medizintechnik2001—
+1K170591Altomed Malhotra Platinum SegmentsAltomed Limited2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K011115, 2001–2017Source: 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 MML? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, 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
K170591Altomed Malhotra Platinum SegmentsAltomed Limited20170

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, K170591 (Altomed Limited, 2017) has gone furthest, with 0 descendants of its own.

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 Heinz Kurz GmbH Medizintechnik

14 FDA decisions under this applicant name. See the company

  • K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik · 2013
  • K071150Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/…Heinz Kurz GmbH Medizintechnik · 2007
  • K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik · 2004
  • K033796Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSHeinz Kurz GmbH Medizintechnik · 2004

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
  • K003646Suturegroove Weight Sizing SetIop, Inc. · 2001

https://510kreport.com/device/K011115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011115: Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011115

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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