510(k) Report

510(k) · Cleared

Cleared

Softshield (TM) 12, 24, 72 Collagen Corneal Shields

K914529510(k) TraditionalCleared Nov 13, 199133-day reviewClass I21 CFR 886.4750

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

Oasis Medical, Inc. · MOE Collagen Corneal Shield

Cleared on Nov 13, 1991 after a 33-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 13, 1991
Review
33 days
Class
Class I
Product code
MOE
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 K914529Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 MOE? 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
Get a 510(k) Report

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 MOE devices

MOE Collagen Corneal Shield: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOE

FDA has decided no MOE device since 2007.

Median 510(k) review, days · MOE

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

Recalls per year · MOE

No recall names MOE since 2007.

Adverse event reports per year · MOE

1in 2016

2007: 22016: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code MOE, 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—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Oasis Medical, Inc.

17 FDA decisions under this applicant name. See the company

  • K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc. · 2022
  • K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc. · 2017
  • K032297Disposable N-PE Mickrokeratome BladesOasis Medical, Inc. · 2003
  • K030401Disposable M2-PE Microkeratome BladesOasis Medical, Inc. · 2003
  • K022205Disposable N-PE Microkeratome BladesOasis Medical, Inc. · 2002

Recent decisions in MOE

The MOE category page

  • K944872Bio-Cor Collagen Corneal ShieldBausch & Lomb Healthcare and Optics Worldwide · 1995
  • K915861Medilens-CS Corneal ShieldChiron Ophthalmics · 1992
  • K913148Collagen Shield for Acute CareVitaphore Corp. · 1991
  • K905825Collagen Shield, Various ModelsChiron Ophthalmics · 1991
  • K902558Collagen Shield for Acute CareVitaphore Corp. · 1990

https://510kreport.com/device/K914529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914529: Softshield (TM) 12, 24, 72 Collagen Corneal Shields.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914529

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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