510(k) Report

510(k) · Cleared

Cleared

Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21

K911120510(k) TraditionalCleared Feb 3, 19941,060-day reviewClass II21 CFR 880.6992

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

Hamo USA, Inc. · MEC Disinfector, Medical Devices

Cleared on Feb 3, 1994 after a 1,060-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Feb 3, 1994
Review
1,060 days
Class
Class II
Product code
MEC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1990200020102020
  1. This deviceK911120 Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Hamo USA, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK983068 Reliance Family of Washer-DisinfectorsSTERIS Corporation · 2000

Most influential descendants

Showing 1 of 1 · See all
  • K983068Reliance Family of Washer-DisinfectorsSTERIS Corporation · 2000 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911120Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21Hamo USA, Inc.1994—
+1K983068Reliance Family of Washer-DisinfectorsSTERIS Corporation2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K911120, 1994–2000Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MEC? 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?

The FDA summary names no predicate by number.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K983068Reliance Family of Washer-DisinfectorsSTERIS Corporation20000

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, K983068 (STERIS Corporation, 2000) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MEC devices

MEC Disinfector, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEC

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEC

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

Recalls per year · MEC

3in 2025

2011: 12013: 12014: 12018: 22020: 12025: 3
2007high 3 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEC

77in 2025

2007: 12008: 42009: 112010: 182011: 182012: 592013: 1512014: 922015: 822016: 802017: 972018: 732019: 782020: 802021: 932022: 852023: 792024: 782025: 77
2007high 151 (2013) · low 1 (2007)2025

MAUDE reports naming product code MEC, 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—01
20081—04
20090—011
20100—018
20110—118
20120—059
20130—1151
20140—192
20150—082
20160—080
20170—097
20180—273
20190—078
20200—180
20210—093
20220—085
20230—079
20240—078
20250—377
20260—0—

Recent decisions in MEC

The MEC category page

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https://510kreport.com/device/K911120 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911120: Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911120

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026