510(k) Report

510(k) · Cleared

Cleared

Pap Ria Kit

K791735510(k) TraditionalCleared Nov 15, 197977-day reviewClass II21 CFR 862.1020

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

Nuclear Medical Systems, Inc. · JFH Acid Phosphatase (Prostatic), Tartrate Inhibited

Cleared on Nov 15, 1979 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 15, 1979
Review
77 days
Class
Class II
Product code
JFH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791735Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 JFH? 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
Get a 510(k) Report

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 JFH devices

JFH Acid Phosphatase (Prostatic), Tartrate Inhibited: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFH

FDA has decided no JFH device since 2007.

Median 510(k) review, days · JFH

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

Recalls per year · JFH

No recall names JFH since 2007.

Adverse event reports per year · JFH

No MAUDE report names JFH 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 Nuclear Medical Systems, Inc.

5 FDA decisions under this applicant name. See the company

  • K821145I-Dhea-Sulfate Ria Kit 125Nuclear Medical Systems, Inc. · 1982
  • K791582Cardio CK-B Ria KitNuclear Medical Systems, Inc. · 1979
  • K780679B-HCG-RiaNuclear Medical Systems, Inc. · 1978
  • K771378Neo TSH-Ria KitNuclear Medical Systems, Inc. · 1977

Recent decisions in JFH

The JFH category page

  • K000257Immulite 2000 Pap, Models L2KPA2, L2KPA6Diagnostic Products Corp. · 2000
  • K981573Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveUnited Biotech, Inc. · 1998
  • K964756Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent KitWano-Tech Corp. · 1997
  • K931701Immulite PapDiagnostic Products Corp. · 1994
  • K925377Imx PapAbbott Laboratories · 1993

https://510kreport.com/device/K791735 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791735: Pap Ria Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791735

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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