510(k) Report

510(k) · Cleared

Cleared

SDL Listeria Monocytogenes Control

K840503510(k) TraditionalCleared Mar 23, 198446-day reviewClass I21 CFR 866.3355

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

Scientific Device Laboratory, Inc. · GSI Antigens, Slide And Tube, All Types, Listeria Monocytogenes

Cleared on Mar 23, 1984 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 23, 1984
Review
46 days
Class
Class I
Product code
GSI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840503Source: 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 GSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 GSI devices

GSI Antigens, Slide And Tube, All Types, Listeria Monocytogenes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GSI

FDA has decided no GSI device since 2007.

Median 510(k) review, days · GSI

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

Recalls per year · GSI

No recall names GSI since 2007.

Adverse event reports per year · GSI

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

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

More from Scientific Device Laboratory, Inc.

28 FDA decisions under this applicant name. See the company

  • K935316Parasafe (R) FixativeScientific Device Laboratory, Inc. · 1994
  • K924893Microsporidium Control SlideScientific Device Laboratory, Inc. · 1993
  • K911059Turbidometric StandardScientific Device Laboratory, Inc. · 1991
  • K895848Pressure Steam SterilizersScientific Device Laboratory, Inc. · 1989
  • K890670Cryptosporidium Control SlideScientific Device Laboratory, Inc. · 1989

https://510kreport.com/device/K840503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840503: SDL Listeria Monocytogenes Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840503

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