510(k) Report

510(k) · Cleared

Cleared

Urosurge Acutrainer

K962770510(k) TraditionalCleared Aug 1, 199616-day reviewClass II21 CFR 876.2040

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

Princeton Regulatory Assoc. · KPN Alarm, Conditioned Response Enuresis

Cleared on Aug 1, 1996 after a 16-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 1, 1996
Review
16 days
Class
Class II
Product code
KPN
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 K962770Source: 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.

Planning a device in KPN? 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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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 KPN devices

KPN Alarm, Conditioned Response Enuresis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPN

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPN

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

Recalls per year · KPN

4in 2022

2022: 4, 4 Class I
2007high 4 (2022) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KPN

1in 2022

2015: 92016: 212017: 1852018: 2862019: 4232020: 362022: 1
2007high 423 (2019) · low 0 (2007)2025

MAUDE reports naming product code KPN, not matched to any one device; reports are not rates.

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
20131—00
20140—00
20150—09
20160—021
20170—0185
20180—0286
20190—0423
20200—036
20210—00
20220—4 (4)1
20230—00
20240—00
20250—00
20260—0—

More from Princeton Regulatory Assoc.

4 FDA decisions under this applicant name. See the company

  • K965136Urosurge Urotherm Fluid Warming SystemPrinceton Regulatory Assoc. · 1998
  • K972158GO Medical Patient Controlled Analgesia DevicesPrinceton Regulatory Assoc. · 1998
  • K973504Urosurge UrostentPrinceton Regulatory Assoc. · 1998

Recent decisions in KPN

The KPN category page

  • K130951SIMSimavita Pty Limited · 2013
  • K971442Hughes Bladder and Bowel Training System (AD-T-18…Humed, Inc. · 1998
  • K971855Potty Pal and Forever-DryDigital Applications, Inc. · 1997
  • K962416Drytime for Bladder Control SilentBio-Systems Research · 1996
  • K955338Drytime for Potty TrainingHealth Sense Intl., Inc. · 1996

https://510kreport.com/device/K962770 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962770: Urosurge Acutrainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962770

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