510(k) Report

PMA · Approved

Approved

Gonodecten

P770010/S001PMAApproved Jun 10, 19800-day reviewClass I21 CFR 866.2660

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

Mediserve International, Inc. · LTS Test Reagents, Neisseria Gonorrhoeae Biochemical

Approved on Jun 10, 1980 through premarket approval, which rests on the device’s own clinical evidence after a 0-day review.

Decided
Jun 10, 1980
Review
0 days
Class
Class I
Product code
LTS
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P770010/S001Source: FDA PMA 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LTS? 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

Does it have a predicate?

PMA decisions do not claim a predicate device.

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 LTS devices

LTS Test Reagents, Neisseria Gonorrhoeae Biochemical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTS

FDA has decided no LTS device since 2007.

Median 510(k) review, days · LTS

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

Recalls per year · LTS

No recall names LTS since 2007.

Adverse event reports per year · LTS

No MAUDE report names LTS 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 Mediserve International, Inc.

2 FDA decisions under this applicant name. See the company

Recent decisions in LTS

The LTS category page

  • K954784Dryside NeisseriaDifco Laboratories, Inc. · 1996
  • P770010/S002GonodectenMediserve International, Inc. · 1981

https://510kreport.com/device/P770010/S001 · printed Nov 5, 2026

Cite this page

510(k) Report. “P770010/S001: Gonodecten.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P770010/S001

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