510(k) Report

510(k) · Cleared

Cleared

Trypan Blue (0.5% in Normal Saline)

K810782510(k) TraditionalCleared May 13, 198151-day reviewClass I21 CFR 864.1850

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

Dutchland Laboratories, Inc. · LGY Trypan Blue

Cleared on May 13, 1981 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 13, 1981
Review
51 days
Class
Class I
Product code
LGY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K810782Source: 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 LGY? 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 LGY devices

LGY Trypan Blue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGY

FDA has decided no LGY device since 2007.

Median 510(k) review, days · LGY

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

Recalls per year · LGY

No recall names LGY since 2007.

Adverse event reports per year · LGY

No MAUDE report names LGY since 2007.

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—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Dutchland Laboratories, Inc.

75 FDA decisions under this applicant name. See the company

  • K821917Waymouth's Powder MediumDutchland Laboratories, Inc. · 1982
  • K821912Mccoy's Powder Medium 5A SuspensionDutchland Laboratories, Inc. · 1982
  • K821913Iscove's Modified Dulbecco Powder MediumDutchland Laboratories, Inc. · 1982
  • K821916Improved Mem-Richter's Powder Modif.Dutchland Laboratories, Inc. · 1982
  • K821918Powdered Rpmi-1603 MediumDutchland Laboratories, Inc. · 1982

https://510kreport.com/device/K810782 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810782: Trypan Blue (0.5% in Normal Saline).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810782

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