510(k) · Cleared
ClearedHughes Bladder and Bowel Training System (AD-T-18, Med-18,Med-1,Med-T-1,Medd-18,Med-38,Med-T-10,Med-T-25,Med-T-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humed, Inc. · KPN Alarm, Conditioned Response Enuresis
Cleared on Jan 8, 1998 after a 262-day review. The FDA summary names no predicate by number.
- Decided
- Jan 8, 1998
- Review
- 262 days
- Class
- Class II
- Product code
- KPN
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against?
The FDA summary names no predicate by number.
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 devicesKPN Alarm, Conditioned Response Enuresis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPN
1in 2013
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
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KPN
1in 2022
MAUDE reports naming product code KPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 185 |
| 2018 | 0 | — | 0 | 286 |
| 2019 | 0 | — | 0 | 423 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 4 (4) | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the contral of incontinence. Hughes Bowel and Bladder System model MeD-18 helps persons with incontinence manage aor overcome bladder contral problems by providing them with a private alarm system to detect when uncontrolled…
Read the full statement (114 words)
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the contral of incontinence.
Hughes Bowel and Bladder System model MeD-18 helps persons with incontinence manage aor overcome bladder contral problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their conditon promptly and with complete discretian at the first sign of bladder or bowel release day ar night.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971442: Hughes Bladder and Bowel Training System (AD-T-18, Med-18,Med-1,Med-T-1,Medd-18,Med-38,Med-T-10,Med-T-25,Med-T-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971442
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026