510(k) Report

510(k) · Cleared

Cleared

Lewis Safe Sleeve

K873960510(k) TraditionalCleared Dec 4, 198767-day reviewClass I21 CFR 872.4565

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

Cheri Lewis, D.D.S. · EIF Accessories, Retractor, Dental

Cleared on Dec 4, 1987 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 4, 1987
Review
67 days
Class
Class I
Product code
EIF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K873960Source: 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 EIF devices

EIF Accessories, Retractor, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIF

FDA has decided no EIF device since 2007.

Median 510(k) review, days · EIF

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

Recalls per year · EIF

No recall names EIF since 2007.

Adverse event reports per year · EIF

2in 2019

2012: 12014: 22015: 82016: 12017: 12019: 2
2007high 8 (2015) · low 0 (2007)2025

MAUDE reports naming product code EIF, 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—01
20130—00
20140—02
20150—08
20160—01
20170—01
20180—00
20190—02
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in EIF

The EIF category page

  • K940785Mouth PropsWorldwide Dental, Inc. · 1994
  • K830187Focus FluidHematology Marketing Assoc. · 1983
  • K830116SulcaringsNorth Pacific Dental, Inc. · 1983

https://510kreport.com/device/K873960 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873960: Lewis Safe Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873960

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