510(k) Report

510(k) · Cleared

Cleared

Three Spike Cup

K922870510(k) TraditionalCleared Apr 8, 1993308-day reviewClass I21 CFR 866.3520

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

Osteo Technology, Inc. · GRF Antiserum, Cf, Rubeola

Cleared on Apr 8, 1993 after a 308-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 8, 1993
Review
308 days
Class
Class I
Product code
GRF
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 K922870Source: 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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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 GRF devices

GRF Antiserum, Cf, Rubeola: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GRF

FDA has decided no GRF device since 2007.

Median 510(k) review, days · GRF

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

Recalls per year · GRF

No recall names GRF since 2007.

Adverse event reports per year · GRF

No MAUDE report names GRF 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 Osteo Technology, Inc.

18 FDA decisions under this applicant name. See the company

  • K926156Replica (TM) Total Hip SystemOsteo Technology, Inc. · 1994
  • K922859Anatomical Type Knee SystemOsteo Technology, Inc. · 1993
  • K922869Total Condylat Type Knee SystemOsteo Technology, Inc. · 1993
  • K925447Oti Orthopedic Wire SystemOsteo Technology, Inc. · 1993
  • K926213Modified Zickel Intramedullary Rod SystemOsteo Technology, Inc. · 1993

Recent decisions in GRF

The GRF category page

  • K852932Measles-Complement Fix Antigen & Negative CLTMicrobix Biosystems, Inc. · 1985

https://510kreport.com/device/K922870 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922870: Three Spike Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922870

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