510(k) Report

510(k) · Cleared

Cleared

Set, Oral Administration

K760251510(k) TraditionalCleared Sep 15, 197658-day reviewClass II21 CFR 876.5980

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

Cis Radiopharmaceuticals, Inc. · LEY Set, Oral Administration

Cleared on Sep 15, 1976 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 15, 1976
Review
58 days
Class
Class II
Product code
LEY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760251Source: 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 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 LEY devices

LEY Set, Oral Administration: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEY

FDA has decided no LEY device since 2007.

Median 510(k) review, days · LEY

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

Recalls per year · LEY

No recall names LEY since 2007.

Adverse event reports per year · LEY

No MAUDE report names LEY 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 Cis Radiopharmaceuticals, Inc.

9 FDA decisions under this applicant name. See the company

  • K791860Ferritin Ria KitCis Radiopharmaceuticals, Inc. · 1979
  • K792063Follicle Stimulating Hormone (FSH) KitCis Radiopharmaceuticals, Inc. · 1979
  • K791202Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 19791 recall
  • K792000Luteinizing Hormone (LH) RiaCis Radiopharmaceuticals, Inc. · 1979
  • K791051Progesterone Radioimmunoassay KitCis Radiopharmaceuticals, Inc. · 1979

https://510kreport.com/device/K760251 · printed Nov 5, 2026

Cite this page

510(k) Report. “K760251: Set, Oral Administration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K760251

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