510(k) Report

510(k) · Cleared

Cleared

Royco Model 970 Hematology Data Analyzer

K780946510(k) TraditionalCleared Jul 27, 197848-day reviewClass II21 CFR 864.5300

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

Hycel, Inc. · JPJ Red-Cell Indices, Calculated

Cleared on Jul 27, 1978 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 27, 1978
Review
48 days
Class
Class II
Product code
JPJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780946Source: 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 JPJ? 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 JPJ devices

JPJ Red-Cell Indices, Calculated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPJ

FDA has decided no JPJ device since 2007.

Median 510(k) review, days · JPJ

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

Recalls per year · JPJ

No recall names JPJ since 2007.

Adverse event reports per year · JPJ

No MAUDE report names JPJ 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 Hycel, Inc.

22 FDA decisions under this applicant name. See the company

  • K802422Hycel Trigyceride II TestHycel, Inc. · 1980
  • K790335Hycel MHycel, Inc. · 1979
  • K782116Ketosteroid Test, Hycel-17Hycel, Inc. · 1979
  • K782176Hycel LDH-Int TestHycel, Inc. · 1979
  • K782100Hycel Counter 333Hycel, Inc. · 1979

Recent decisions in JPJ

The JPJ category page

  • K904675QBC System MCHCBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
  • K761304JTB 700 Hematology AnalyzerJ.T. Baker Chemical Co. · 1977

https://510kreport.com/device/K780946 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780946: Royco Model 970 Hematology Data Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780946

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