510(k) Report

510(k) · Cleared

Cleared

Perry-Kolberg (PK) HA-Coated Titanium Sleeve

K000151510(k) TraditionalCleared Apr 10, 200082-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

Integrated Orbital Implants, Inc. · MQU Ocular Peg

Cleared on Apr 10, 2000 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 10, 2000
Review
82 days
Class
Class II
Product code
MQU
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K000151Source: 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 has not posted a summary or statement for it, 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 MQU devices

MQU Ocular Peg: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQU

FDA has decided no MQU device since 2007.

Median 510(k) review, days · MQU

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

Recalls per year · MQU

No recall names MQU since 2007.

Adverse event reports per year · MQU

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code MQU, 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—01
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 Integrated Orbital Implants, Inc.

5 FDA decisions under this applicant name. See the company

  • K003338Bio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. · 20011 recall
  • K982562Bio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. · 19982 recalls
  • K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 19981 recall
  • K891137Motility Orbital ImplantIntegrated Orbital Implants, Inc. · 1989

Recent decisions in MQU

The MQU category page

  • K980822Titanium Peg SystemFci Ophthalmics, Inc. · 1998
  • K974203Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 19981 recall
  • K971583Medpor Ocular Screw and AcceossoriesPorex Technologies Corp. · 1997

https://510kreport.com/device/K000151 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000151: Perry-Kolberg (PK) HA-Coated Titanium Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000151

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