510(k) Report

510(k) · Cleared

Cleared

Oms Silicone Oil Injector

K844895510(k) TraditionalCleared Jun 24, 1985189-day reviewClass III21 CFR 886.4275

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

Optical Micro Systems, Inc. · LWL Fluid, Intraocular

Cleared on Jun 24, 1985 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 24, 1985
Review
189 days
Class
Class III
Product code
LWL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K844895Source: 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.

Planning a device in LWL? 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?

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 LWL devices

LWL Fluid, Intraocular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWL

1in 2025

2007: 22008: 32009: 12010: 22011: 12012: 32013: 52014: 12015: 22016: 22018: 12020: 12021: 32022: 12023: 112024: 22025: 1
2007high 11 (2023) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWL

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

Recalls per year · LWL

No recall names LWL since 2007.

Adverse event reports per year · LWL

27in 2025

2007: 42008: 112009: 72010: 162011: 92012: 62013: 12014: 32015: 32016: 132017: 32018: 62019: 22020: 72021: 122022: 132023: 182024: 162025: 27
2007high 27 (2025) · low 1 (2013)2025

MAUDE reports naming product code LWL, 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
20072—04
20083—011
20091—07
20102—016
20111—09
20123—06
20135—01
20141—03
20152—03
20162—013
20170—03
20181—06
20190—02
20201—07
20213—012
20221—013
202311—018
20242—016
20251—027
20260—0—

More from Optical Micro Systems, Inc.

21 FDA decisions under this applicant name. See the company

  • K950218Oms Slimline Phaco HandpieceOptical Micro Systems, Inc. · 1995
  • K946054DiplomaxOptical Micro Systems, Inc. · 1995
  • K935223Ophthalmic Surgical SystemOptical Micro Systems, Inc. · 1994
  • K935226I/V PoleOptical Micro Systems, Inc. · 1994
  • K935003Electric I/V Pole or EIVP2Optical Micro Systems, Inc. · 1994

Recent decisions in LWL

The LWL category page

https://510kreport.com/device/K844895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K844895: Oms Silicone Oil Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844895

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