REUSABLE ADULT INCONTINENT DIAPER
FDA 510(k) clearance K883787 · decided 1988-11-07
Clearance details
- K-number
- K883787
- Device name
- REUSABLE ADULT INCONTINENT DIAPER
- Applicant
- Intera Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-07
- Decision date
- 1988-11-07
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- EYQ
- Device class
- 1
- Regulation number
- 876.5920
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Chattanooga, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intera Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784) | Advanced Bioresearch Assoc. | 1995-05-03 |
| KIT PAK INCONTINENT SKIN CARE KIT (K932310) | Kit Pak, Inc. | 1994-06-01 |
| DEODORIZING AND SOUND MUFFLING ANAL PAD (K903342) | Biological Resistance, Inc. | 1990-10-23 |
| LIB SYSTEM, BABY/ADULT DIAPER (K891686) | Intera Corp. | 1989-05-31 |
| INTERA SHIELD AND INTERA UNDERGARMENT (K885185) | Intera Corp. | 1989-02-08 |
| DRIPRIDE PROVIDE SLIM (K883894) | Weyerhaeuser Co. | 1989-01-30 |
| DRIPRIDE ULTRA INCONTINENT PAD (K883895) | Weyerhaeuser Co. | 1989-01-30 |
| DRY COMFORT UNDERGARMENT (K882418) | Health Tec, Inc. | 1988-09-29 |
| AT EASE STRESS PAD (K880454) | Hospital Specialty Co. | 1988-06-16 |
| AT EASE ADULT DIAPER (K880455) | Hospital Specialty Co. | 1988-04-14 |
| CHICOPEE ADULT INCONTINENCE SHIELDS (K880338) | Chicopee, Inc. | 1988-03-31 |
| DRIPRIDE PROVIDE ULTRA (K872059) | Weyerhaeuser Co. | 1988-03-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/s recall (Z-0524-2012) | Heritage Labs International LLC | 2012-01-11 |