FDA product code KPN: Alarm, Conditioned Response Enuresis
KPN is the FDA product code for alarm, conditioned response enuresis. It is a Class II device, regulated under 21 CFR 876.2040 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 37 510(k) submissions under KPN, from 28 different applicants. The average 510(k) review took 112 days (median 99). FDA has posted 4 recalls for KPN devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Alarm, Conditioned Response Enuresis |
| Device class | Class II |
| Regulation | 21 CFR 876.2040 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPN clearance
Top KPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Health Sense Intl., Inc. | 4 | 1996-03-12 |
| Travis Industries, Inc. | 3 | 1990-09-12 |
| Biosonics, Inc. | 3 | 1988-08-30 |
| Laborie Medical Technologies, Ltd. | 2 | 1993-11-24 |
| Nite Train-R Enterprises, Inc. | 2 | 1988-01-19 |
23 more applicants have KPN clearances. See the full list in Caduvo.
Most recent KPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130951 | Simavita Pty Limited | SIM | 2013-08-22 | 139 |
| K971442 | Humed, Inc. | 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 | 1998-01-08 | 262 |
| K971855 | Digital Applications, Inc. | POTTY PAL AND FOREVER-DRY | 1997-08-18 | 90 |
| K962770 | Princeton Regulatory Assoc. | UROSURGE ACUTRAINER | 1996-08-01 | 16 |
| K962416 | Bio-Systems Research | DRYTIME FOR BLADDER CONTROL SILENT | 1996-07-22 | 83 |
Recalls for KPN devices
4 product recalls in 1 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2022-09-30.
| Year | Recalls |
|---|---|
| 2022 | 4 |
Frequently asked questions
What is FDA product code KPN?
KPN is the FDA product code for alarm, conditioned response enuresis. It is a Class II device, regulated under 21 CFR 876.2040 and reviewed by the Gastroenterology and Urology panel.
What device class is KPN?
Class II, regulation 21 CFR 876.2040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPN?
Across 37 cleared submissions the average was 112 days from receipt to decision (median 99).
Which companies have the most KPN clearances?
Health Sense Intl., Inc. (4); Travis Industries, Inc. (3); Biosonics, Inc. (3); Laborie Medical Technologies, Ltd. (2); Nite Train-R Enterprises, Inc. (2).
Have KPN devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2022-09-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KPN
- Run a recall and safety report across every KPN manufacturer
- Watch product code KPN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times