510(k) Report

510(k) · Cleared

Cleared

Klorman

K923693510(k) TraditionalCleared Jan 23, 19961,279-day reviewClass I21 CFR 880.6890

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

Matrix Medica, Inc. · LRJ Disinfectant, Medical Devices

Cleared on Jan 23, 1996 after a 1,279-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 23, 1996
Review
1,279 days
Class
Class I
Product code
LRJ
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 K923693Source: 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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  • 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 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 LRJ devices

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

FDA decisions per year · LRJ

FDA has decided no LRJ device since 2007.

Median 510(k) review, days · LRJ

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

Recalls per year · LRJ

4so far in 2026, the most since 2007

2009: 12013: 12021: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

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

Adverse event reports per year · LRJ

70in 2025

2007: 1262008: 722009: 392010: 182011: 402012: 372013: 312014: 182015: 152016: 132017: 62018: 152019: 122020: 732021: 4972022: 1712023: 952024: 1162025: 70
2007high 497 (2021) · low 6 (2017)2025

MAUDE reports naming product code LRJ, 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—0126
20080—072
20090—139
20100—018
20110—040
20120—037
20130—131
20140—018
20150—015
20160—013
20170—06
20180—015
20190—012
20200—073
20210—1497
20220—0171
20230—095
20240—0116
20250—070
20260—4—

More from Matrix Medica, Inc.

14 FDA decisions under this applicant name. See the company

  • K961536FlexscopeMatrix Medica, Inc. · 1996
  • K921982Matrx Hope (R) 5 ResuscitatorMatrix Medica, Inc. · 1994
  • K915353Matrx Medical Maximizer 1000 and 2000 Vacuum PumpMatrix Medica, Inc. · 1991
  • K912661Matrx, Pyramid Triangle BandageMatrix Medica, Inc. · 1991
  • K900551Matrx Disposable Non-Invasive Gelled Pacing Elec.Matrix Medica, Inc. · 1990

Recent decisions in LRJ

The LRJ category page

  • K992661Control Iii EliteMaril Products, Inc. · 1999
  • K991509Pro-Portion Cleaner/DisinfectantSultan Chemists, Inc. · 1999
  • K984485Microstat 2Chemlink Laboratories, LLC · 1999
  • K983947Amerse 2STERIS Corporation · 1998
  • K983869Dispatch Hospital Cleaner Disinfectant Towels with BleachCaltech Industries, Inc. · 1998

https://510kreport.com/device/K923693 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923693: Klorman.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923693

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