510(k) Report

510(k) · Cleared

Cleared

Royco Model 371 Super Dilutor

K791644510(k) TraditionalCleared Sep 19, 197927-day reviewClass I21 CFR 864.5240

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

Royco Instruments · GKH Apparatus, Automated Blood Cell Diluting

Cleared on Sep 19, 1979 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 19, 1979
Review
27 days
Class
Class I
Product code
GKH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791644Source: 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 GKH? 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?

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 GKH devices

GKH Apparatus, Automated Blood Cell Diluting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKH

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKH

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

Recalls per year · GKH

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · GKH

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code GKH, 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—12
20101—10
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 Royco Instruments

4 FDA decisions under this applicant name. See the company

  • K800104Royco Model 951 Cell MixerRoyco Instruments · 1980
  • K791867Royco Model 921 Cell CounterRoyco Instruments · 1979
  • K790442Isotonic DiluentRoyco Instruments · 1979

Recent decisions in GKH

The GKH category page

  • K100684Celltracks Autoprep System Model:9541Veridex, LLC · 2010
  • K040077Immunicon Celltracks Autoprep SystemImmunicon Corp. · 20042 recalls
  • K022512Cellprep Sample Preparation System, Model 9518Immunicon Corp. · 2002
  • K021150Coulter CellprepBeckman Coulter, Inc. · 2002
  • K935953Coulter Multi Q PrepCoulter Corp. · 1994

https://510kreport.com/device/K791644 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791644: Royco Model 371 Super Dilutor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791644

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