510(k) Report

PMA · Approved

Approved

Repro-Med - THD

P820034/S002PMAApproved May 12, 1987827-day reviewClass III

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

Repro-Med Systems, Inc. · LOA Device, Testicular Hypothermia

Approved on May 12, 1987 through premarket approval, which rests on the device’s own clinical evidence after an 827-day review.

Decided
May 12, 1987
Review
827 days
Class
Class III
Product code
LOA
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 P820034/S002Source: FDA PMA database · How lineage is built

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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 LOA? 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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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 LOA devices

LOA Device, Testicular Hypothermia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOA

FDA has decided no LOA device since 2007.

Median 510(k) review, days · LOA

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

Recalls per year · LOA

No recall names LOA since 2007.

Adverse event reports per year · LOA

No MAUDE report names LOA 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 Repro-Med Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
  • K981506Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum…Repro-Med Systems, Inc. · 1998
  • P820034/S005Repro-Med - THDRepro-Med Systems, Inc. · 1997
  • K933652Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc. · 19941 recall
  • P820034/S004Repro-Med - THDRepro-Med Systems, Inc. · 1993

Recent decisions in LOA

The LOA category page

  • P820034/S005Repro-Med - THDRepro-Med Systems, Inc. · 1997
  • P820034/S004Repro-Med - THDRepro-Med Systems, Inc. · 1993
  • P820034/S003Repro-Med - THD Address Change / Manu. FacilityRepro-Med Systems, Inc. · 1993
  • P820034/S001Repro-Med - THDRepro-Med Systems, Inc. · 1985
  • P820034Repro-Med - THDRepro-Med Systems, Inc. · 1984

https://510kreport.com/device/P820034/S002 · printed Nov 6, 2026

Cite this page

510(k) Report. “P820034/S002: Repro-Med - THD.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820034/S002

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