510(k) Report

510(k) · Cleared

Cleared

Osmed Tissue Expander

K010852510(k) TraditionalCleared Aug 13, 2001145-day reviewClass II21 CFR 886.3320

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

Iop, Inc. · NFM Expander, Tissue, Orbital

Cleared on Aug 13, 2001 after a 145-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 13, 2001
Review
145 days
Class
Class II
Product code
NFM
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK010852 Osmed Tissue ExpanderIop, Inc. · 2001
  2. Descendant · cites it directly · 2 of its ownK060151 Orbital Tissue Expander (Ote)Innovia, LLC · 2006
  3. Descendant · 2 generations on · 1 of its ownK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
  4. Descendant · 3 generations on · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009

Most influential descendants

Showing 3 of 3 · See all
  • K060151Orbital Tissue Expander (Ote)Innovia, LLC · 2006 · cites it directly2descendants
  • K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007 · 2 generations on1descendant
  • K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010852Osmed Tissue ExpanderIop, Inc.2001—
+1K060151Orbital Tissue Expander (Ote)Innovia, LLC2006—
+2K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc.2007—
+3K083342Orbital Reconstructive Implant IIEvera Medical, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200910
FIG. 1 — Lineage of K010852, 2001–2009Source: 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 NFM? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060151Orbital Tissue Expander (Ote)Innovia, LLC20062

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, K060151 (Innovia, LLC, 2006) has gone furthest, with 2 descendants of its own.

How does its category compare?

All NFM devices

NFM Expander, Tissue, Orbital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFM

FDA has decided no NFM device since 2007.

Median 510(k) review, days · NFM

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

Recalls per year · NFM

No recall names NFM since 2007.

Adverse event reports per year · NFM

No MAUDE report names NFM since 2007.

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
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
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
  • K003646Suturegroove Weight Sizing SetIop, Inc. · 2001
  • K994289SuturegrooveIop, Inc. · 2000

Recent decisions in NFM

The NFM category page

  • K060151Orbital Tissue Expander (Ote)Innovia, LLC · 2006

https://510kreport.com/device/K010852 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010852: Osmed Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010852

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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